12 b. This information was originally contained in the ...12 b. This information was originally contained in the February 13, 2009 submittal as: ATTACHMENT - Chron - 1 · , Withhold

12 b

This information was originally contained in the February 13 2009 submittal as

ATTACHMENT - Chron - 1

12 b

This information was originally contained in the February 13 2009 submittal as

ATTACHMENT - Chron - 1

middot Withhold from public disclosure under 10 CFR 2390

ATTACHMENT

Chron-1

VariSource Event and Maintenance Timeline

Withhold from public disclosure under 10 CFR 2390


ATTACHMENT

Chron-1




Chronological Sequence of EVents at Four VS sites of Interest

MTSN-shy S~e Manufacture Inslllil lolSE

lacatton Date Date

-8123107Texas

2ndSE

1214107

3rd5E

212810B

41h5E

81412008 Active Cye =767

DummyCyc 10B7

Servlbullbull Call

S11712008 ~ ActIVe wire conslriction errors

5th5E

9132008 Active eye 234

Dummy eyc 3 332

Service call

91312008 bull Active park switchdrive failure error

6thSE

121212008 Actwe eye = 688

Dummy eyc 900

121212008 - Source stuck out rocovered

121412008

MTSN 51te

Location

~penn

Manufacture Date

Inslllil Date

IslSE 2nd SE

21150S

3rdSE

52210B

Servlce Can

6192008 bull Active wire slippage errols

41hSE

9102008 Active Cye - 662

Dummy Cye = 1408

51hSE

121111200S AcUve Cyc 493

Dummy Cyc = 526

121112008middot Source stuck out recovered

1211212008

SHe Manufacture InstaMTSN

Location Oat Date ltSE

- Cal~ ~Bo7

S~e Manufacture InslllllMTSN

Location Date Oate isiS

~Nebr -5130107

2ndSE

615107

2ndSE

9117107

3rdSE

911107

3rd SE

121707

I I I I I I I I I I I I II I I I

4lhSE

11612008 ActveCyc 103

Dummy Cye bull 106

4thSE

311112008 Activo Cye c 52

Dummy Cyebull 27

51hSE

31712008 Active Cye 73

Dummy Cye bull 55

5th SE

6252008 Ael~o Cyebull 205 Dummy Cyebull 97

61hSE

6121200B Active Cyc = 68

Dummy Cyc 41

51hSE

913200B ActiveCyc 85

Dummy Cye = 43

7thSE

9131200B Activ Cye bull 154

Dummy Cyebull 135

7th SE

121812008 Activ Cye bull 109 Dummy eye 62

Servlc Call

9912008 - Active wire constriction errors

Service Can

16i2009 ~ Active wire constriction errors

BlbSE

121292008 Active Cyc 154

Dummy Cye c 135

1212912008 - Source stuck out recovered

123112008

Withhold from publlc dlsclosure under 10 CFR 2390



MTSN S~e Manufacture Inslllil

lolSE 2ndSE 3rd5E 41h5E Servl bullbull Call 5th5E Service call 6thSE lacatton Date Date

pound -8123107 81412008

S117 12008 ~ ActIVe wire 9132008 91312008 bull Active park

121212008 121212008 - Source Texas 1214107 2281OB Active Cye = 767

conslriction errors Active eye 234

switchdrive failure error Actrve eye = 688 stuck out rocovered

DummyCyc 10B7 Dummy eyc 3 332 Dummy eyc 900 121412008

MTSN 51te Manufacture Inslllil

IslSE 2nd SE 3rdSE Servlce Can 41hSE 51hSE Location Date Date

~penn 6192008 bull Active wire 9102008 1211112008 1211112008middot Source

211508 512210B slippage errols

Active Cye - 662 AcUve Cyc 493 stuck out recovered Dummy Cye = 1408 Dummy Cyc = 526 1211212008

SHe Manufacture Insta I

MTSN Location Oat Date

ltSE 2ndSE 3rdSE I 4thSE 51hSE 61hSE 7thSE Servlc Call BlbSE I - ~Bo7 111612008 3172006 611212008 91312008 121292008 1212912008 - Source

Cal~ 615107 911107 I ActveCyc 103 Active Cye 73 Active Cyc = 68 Activ Cye bull 154 9912008 - Active wire

Active Cyc 154 stuck out recovered I constriction errors I Dummy Cye bull 106 Dummy Cye bull 55 Dummy Cyc 41 Dummy Cye bull 135 Dummy Cye c 135 123112008

I I I

S~e Manufacture Inslllll

MTSN isiS 2ndSE 3rd SE 4thSE 5th SE 51hSE 7th SE Service Can Location Date Oate I

~Nebr -513007

I 311112008 62512008 91312008 121812008 I 16i2009 ~ Active wire 9117107 1217107 Activo Cye c 52 Acl~o Cye bull 205 ActiveCyc 85 Activ Cye bull 109

constriction errors Dummy Cye bull 27 Dummy Cye bull 97 Dummy Cye = 43 Dummy eye 62


Varian Medical Systems Inc

Proprietary Filing

Company Confidential


Proprietary Filing


Varian Medical Systems Inc Proprietary Filing - Company Confidential

Varian Medical Systems Inc Proprietary filing

The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc

This document is submitted in support of

1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)

This document contains Attachments

1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States

~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris

5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs

1 Information cited in the Part 30 and Part 21 reports

Two tables cited in the reports are provided in this document

The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES

The list of all VariSource sites in the United States is included as Attachment VS ALL SITES

2 VariSource EVent Background

Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence

1 A regularly scheduled source exchange is completed

2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire

3 The source fails to retract and is stuck outside the HDR unit

The source jamming has occurred during either the third of fourth PVT

While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room





















Varian Medical Systems Inc - Proprietary Filing Company Confidential

In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters

There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21




Varian Medical Systems Inc bull Proprietary Filing Company Confidential

2b VariSourcemiddot Hershey Medical Center- December 112008

3



3

Varian Medical Systems Inc - Proprietary Filing - Company Confidential

r HDR unit compared to GammaMed HDR unit

The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains

(The rest of this page is intentionally blank)

4





4


Some of the differences between the two afterloaders are stated in the following table

4 Compare and contrast GammaMed and VariSource events

The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated

Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture

5






5


5 VariSource - Radiation exposure to personnel during event and recovery

In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody

1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry

6 VariSource - Recurrence prevention

Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites

Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document

7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components

Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________

present in any m

_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~

----------------

6









Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _

present in any m

The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~

----------------

6

Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage

Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire

11 VariSource bull Evidence of galling corrosion pitting in the wedge block

-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting

12 VariSource bull Wedge block material

The wedge block is made from alum in machining

13 VariSource - Presence of PTFE in the debris

PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont

PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust

15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites

I

14 VariSource shy Need for a lubricant and efficacy

A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators

7

Varian Medical Systems Inc bull Proprietary Filing - Company Confidential

10 VariSource - Damage to wires and evidence of pitting and damage



The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting

- -- -






14 VariSource - Need for a lubricant and efficacy


15 VariSource - Source contamination during transportation

This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites

7

I


16 VariSource - Tech Tip

Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th

bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1

17 VariSource - Tech Tip TT-VS-01247B Validation Support

Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test

The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error

Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen

18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution

CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1

19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis

The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1

20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull

Varian is investigating the developme re

8













20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull


8


21 VariSource - Retract Error Retrospective Analysis

9



9

Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential

The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending

bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports

A regularly scheduled audit was conducted conformances were registered by the auditing

non-

conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~

at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed

Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures

All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern

]0




--~ -------------- 22 VariSource-


non-


at the sOUrce manufacturin D 51 ~uring ms were reviewed



]0


23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified

24 VariSourcemiddot dummy wire use and load pattern

All FSEs use the same protocol for loading a VariSource dummy wire

25 VariSourcemiddot 10mm measurement of recovered wires

A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation

Investigation

Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)


11


23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified





Investigation



11


26 VariSource dust

Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967

Excerpts from the study are in Attachment INTERTEK 1

27 VariSource - Role of room ventilation as possible contamination source

Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block

The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1

Investigation

Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728

Conclusion

There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~

The stainless steel and aluminum storage and guidance track

There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote

28 VariSource and GammaMed - FSE Training Records Review and Summary

All FSEs training records are current and complete

All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units

Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent

11


26 VariSource dust

Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967





Investigation


Conclusion








11

(


After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted

29 GammaMed __

United Kingdom provides un au was completed by two Varian

Quality Engineers in February 2007 with a scope to review

bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records

The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed

An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009

-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued

certificate

Ongoing tasks and expected completion date

30 VariSource - Analysis ofmaterials used near and around the source wire

Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events

rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit

31 VariSource - Analysis of debris

Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009



29 GammaMed __







certificate


30 VariSource - Analysis of materials used near and around the source wire






32 VariSource - Clinical housekeeping fluids used at affected sites

Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009

33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center

The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009

34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites

This task is ongoing with an expected completion date of March 27 2009

35 GammaMed and VariSource - Comparison ofevents

A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed

36 Lessons learned

Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed


14






34 GammaMed and VariSource - Analysis of applicator Usage at affected sites

This task is ongoing with an expected completion date of March 272009

35 GammaMed and VariSource - Comparison of events


36 Lessons learned



14

-~J

ATTACHMENT

Chron-1


-~J

ATTACHMENT

Chron-1


Chronological Sequence of Events at Four VS sites of Interest

lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC

II11itall Date 1st Si

20a SE 3rd S[

i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE

VSH t -71 t

b420[J8 ACllcshy ffil

0 2068 Ictllfe w(r~

9J3f~OOU 23oi

VJlttuOii ~Actfie Pl(H~ichlCftVe failure

12tu200e Atl~ Cre oo~

Zi2i2JOt~ bull Sou~ stutk O(t nrovcred

Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS

I I t I

M1 SN

Site Location

Maftufacturu Oa~Q

Install Datu 1st 5E 2nd SE 3td Sf

t t S~rv~cl Call 4th Sf ~th SE

ponn _ 1150( $1l2iOtJ +-ft

f 6tJbullt-Oil-Actlve I IHfl

9f102000 662

121112009 ArUWcCyc4~j3

2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld

t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy

I I I I

VfSN

sac LccLltlon

MOI-rlIJ1aclull Dall)

InstallDa1~ 1stSr ImJSE 3rdSE

(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE

C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

55

fSIb2000 ActPo-eCYC

)wn01V Cc lt41

i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe

DtIIlHlly etc 135 (OOstrittI(Ht eno(l

1212912008 154 ~ 135

1212lf1oo6middot 8laquos~tlkotitfeCQre-d

1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate

Instart Oati 1st 1St 2nd SE rd St

f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call

i4~lt ~

__ rl~fj ~

l~F7 ~

t~H)1

mJ2(ID8 r -~~~7

612 ~OOI 11lZOOB -f -4~

12ISIZ00S 109 J6I20~~AC1Newre

-2 con~tricttone-rfJrt


lgtlTSW Sitcc Maflqf1tturlll II11itall

1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I

41SE SeNiceC~U 5th SI

I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~

VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred

Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij

I I I I I

MT$N Site Maftufacturu Install

1t SF I Location Oa~Q Datu

2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE

I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ

I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~

I I I I

VfSN sac MOI-rlIJ1aclull Install

1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE

LccLltlon Dall) Da1~ d SE I 4th SE SnSE

I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire

C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d

I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006

I I I I

MfSN Silo ManifncUHc Instart

1st Sf f 7hSE srvlltcn

lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se

I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS

I ~ if jU ~B2 con~trictton erfJrt

ATTACHMENT

INTERTEK 1

Analysis of wedge block and debris

ATTACHMENT

INTERTEK 1


Excerpts from the Intertek study on the wedge block and debris

Results Interpretations and Opinions

The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation

-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy



The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation

-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy

The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package

2


2

MIC 728 Clinical Deposit VS448

At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above

3



3

In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)


Clinical Oeposit V8448

R11400

Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)

5


R11400

Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)

5

Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together

What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks

We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine

6


What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks


6

7 7

9 9

The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well

The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra

What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking

10




10

MICW 728 Non Clinical Deposit

11


11

From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same

What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place

J3



J3

14 14

The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below

MICW 128 VS447 wedge block entry end

J5



J 5

MICW 728 VS447 wedge block ~

16


16

In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris

Quite apart from this are detected and this is characteristic of the clinical deposit

In conclusion

The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology

17


Quite apart from this of the clinical deposit

In conclusion

are detected and this is characteristic


17


ATTACHMENT

Chron-1




ATTACHMENT

Chron-1






lacatton Date Date

-8123107Texas

2ndSE

1214107

3rd5E

212810B

41h5E

81412008 Active Cye =767

DummyCyc 10B7

Servlbullbull Call


5th5E


Dummy eyc 3 332

Service call


6thSE

121212008 Actwe eye = 688

Dummy eyc 900


121412008

MTSN 51te

Location

~penn

Manufacture Date

Inslllil Date

IslSE 2nd SE

21150S

3rdSE

52210B

Servlce Can


41hSE

9102008 Active Cye - 662

Dummy Cye = 1408

51hSE

121111200S AcUve Cyc 493

Dummy Cyc = 526


1211212008



- Cal~ ~Bo7



~Nebr -5130107

2ndSE

615107

2ndSE

9117107

3rdSE

911107

3rd SE

121707


4lhSE

11612008 ActveCyc 103

Dummy Cye bull 106

4thSE


Dummy Cyebull 27

51hSE


Dummy Cye bull 55

5th SE


61hSE


Dummy Cyc 41

51hSE


Dummy Cye = 43

7thSE


Dummy Cyebull 135

7th SE


Servlc Call


Service Can


BlbSE

121292008 Active Cyc 154

Dummy Cye c 135


123112008






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11







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11


26 VariSource dust






Investigation


Conclusion








11


26 VariSource dust






Investigation


Conclusion








11

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29 GammaMed __







certificate
















36 Lessons learned



14










36 Lessons learned



14

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ATTACHMENT

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9 9




10




10


11


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J3



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14 14



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16


16



In conclusion


17



In conclusion



17




lacatton Date Date

-8123107Texas

2ndSE

1214107

3rd5E

212810B

41h5E

81412008 Active Cye =767

DummyCyc 10B7

Servlbullbull Call


5th5E


Dummy eyc 3 332

Service call


6thSE

121212008 Actwe eye = 688

Dummy eyc 900


121412008

MTSN 51te

Location

~penn

Manufacture Date

Inslllil Date

IslSE 2nd SE

21150S

3rdSE

52210B

Servlce Can


41hSE

9102008 Active Cye - 662

Dummy Cye = 1408

51hSE

121111200S AcUve Cyc 493

Dummy Cyc = 526


1211212008



- Cal~ ~Bo7



~Nebr -5130107

2ndSE

615107

2ndSE

9117107

3rdSE

911107

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121707


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11612008 ActveCyc 103

Dummy Cye bull 106

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Dummy Cyebull 27

51hSE


Dummy Cye bull 55

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61hSE


Dummy Cyc 41

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Dummy Cye = 43

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Dummy Cyebull 135

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121292008 Active Cyc 154

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11


26 VariSource dust






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29 GammaMed __







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36 Lessons learned



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36 Lessons learned



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29 GammaMed __







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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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36 Lessons learned



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29 GammaMed __







certificate









29 GammaMed __







certificate
















36 Lessons learned



14










36 Lessons learned



14

-~J

ATTACHMENT

Chron-1


-~J

ATTACHMENT

Chron-1



lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC


20a SE 3rd S[


VSH t -71 t


0 2068 Ictllfe w(r~

9J3f~OOU 23oi





I I t I

M1 SN

Site Location

Maftufacturu Oa~Q





9f102000 662




I I I I

VfSN

sac LccLltlon




C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

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fSIb2000 ActPo-eCYC

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1212912008 154 ~ 135


1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate



i4~lt ~

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l~F7 ~

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612 ~OOI 11lZOOB -f -4~










I I I I I






I I I I







I I I I






ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17



9



9





non-





]0




--~ -------------- 22 VariSource-


non-





]0







Investigation



11







Investigation



11


26 VariSource dust






Investigation


Conclusion








11


26 VariSource dust






Investigation


Conclusion








11

(



29 GammaMed __







certificate









29 GammaMed __







certificate
















36 Lessons learned



14










36 Lessons learned



14

-~J

ATTACHMENT

Chron-1


-~J

ATTACHMENT

Chron-1



lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC


20a SE 3rd S[


VSH t -71 t


0 2068 Ictllfe w(r~

9J3f~OOU 23oi





I I t I

M1 SN

Site Location

Maftufacturu Oa~Q





9f102000 662




I I I I

VfSN

sac LccLltlon




C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

55

fSIb2000 ActPo-eCYC

)wn01V Cc lt41



1212912008 154 ~ 135


1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate



i4~lt ~

__ rl~fj ~

l~F7 ~

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612 ~OOI 11lZOOB -f -4~










I I I I I






I I I I







I I I I






ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17





non-





]0




--~ -------------- 22 VariSource-


non-





]0







Investigation



11







Investigation



11


26 VariSource dust






Investigation


Conclusion








11


26 VariSource dust






Investigation


Conclusion








11

(



29 GammaMed __







certificate









29 GammaMed __







certificate
















36 Lessons learned



14










36 Lessons learned



14

-~J

ATTACHMENT

Chron-1


-~J

ATTACHMENT

Chron-1



lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC


20a SE 3rd S[


VSH t -71 t


0 2068 Ictllfe w(r~

9J3f~OOU 23oi





I I t I

M1 SN

Site Location

Maftufacturu Oa~Q





9f102000 662




I I I I

VfSN

sac LccLltlon




C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

55

fSIb2000 ActPo-eCYC

)wn01V Cc lt41



1212912008 154 ~ 135


1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate



i4~lt ~

__ rl~fj ~

l~F7 ~

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mJ2(ID8 r -~~~7

612 ~OOI 11lZOOB -f -4~










I I I I I






I I I I







I I I I






ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17







Investigation



11







Investigation



11


26 VariSource dust






Investigation


Conclusion








11


26 VariSource dust






Investigation


Conclusion








11

(



29 GammaMed __







certificate









29 GammaMed __







certificate
















36 Lessons learned



14










36 Lessons learned



14

-~J

ATTACHMENT

Chron-1


-~J

ATTACHMENT

Chron-1



lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC


20a SE 3rd S[


VSH t -71 t


0 2068 Ictllfe w(r~

9J3f~OOU 23oi





I I t I

M1 SN

Site Location

Maftufacturu Oa~Q





9f102000 662




I I I I

VfSN

sac LccLltlon




C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

55

fSIb2000 ActPo-eCYC

)wn01V Cc lt41



1212912008 154 ~ 135


1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate



i4~lt ~

__ rl~fj ~

l~F7 ~

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612 ~OOI 11lZOOB -f -4~










I I I I I






I I I I







I I I I






ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17


26 VariSource dust






Investigation


Conclusion








11


26 VariSource dust






Investigation


Conclusion








11

(



29 GammaMed __







certificate









29 GammaMed __







certificate
















36 Lessons learned



14










36 Lessons learned



14

-~J

ATTACHMENT

Chron-1


-~J

ATTACHMENT

Chron-1



lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC


20a SE 3rd S[


VSH t -71 t


0 2068 Ictllfe w(r~

9J3f~OOU 23oi





I I t I

M1 SN

Site Location

Maftufacturu Oa~Q





9f102000 662




I I I I

VfSN

sac LccLltlon




C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

55

fSIb2000 ActPo-eCYC

)wn01V Cc lt41



1212912008 154 ~ 135


1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate



i4~lt ~

__ rl~fj ~

l~F7 ~

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mJ2(ID8 r -~~~7

612 ~OOI 11lZOOB -f -4~










I I I I I






I I I I







I I I I






ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17



29 GammaMed __







certificate









29 GammaMed __







certificate
















36 Lessons learned



14










36 Lessons learned



14

-~J

ATTACHMENT

Chron-1


-~J

ATTACHMENT

Chron-1



lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC


20a SE 3rd S[


VSH t -71 t


0 2068 Ictllfe w(r~

9J3f~OOU 23oi





I I t I

M1 SN

Site Location

Maftufacturu Oa~Q





9f102000 662




I I I I

VfSN

sac LccLltlon




C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

55

fSIb2000 ActPo-eCYC

)wn01V Cc lt41



1212912008 154 ~ 135


1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate



i4~lt ~

__ rl~fj ~

l~F7 ~

t~H)1

mJ2(ID8 r -~~~7

612 ~OOI 11lZOOB -f -4~










I I I I I






I I I I







I I I I






ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17










36 Lessons learned



14










36 Lessons learned



14

-~J

ATTACHMENT

Chron-1


-~J

ATTACHMENT

Chron-1



lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC


20a SE 3rd S[


VSH t -71 t


0 2068 Ictllfe w(r~

9J3f~OOU 23oi





I I t I

M1 SN

Site Location

Maftufacturu Oa~Q





9f102000 662




I I I I

VfSN

sac LccLltlon




C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

55

fSIb2000 ActPo-eCYC

)wn01V Cc lt41



1212912008 154 ~ 135


1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate



i4~lt ~

__ rl~fj ~

l~F7 ~

t~H)1

mJ2(ID8 r -~~~7

612 ~OOI 11lZOOB -f -4~










I I I I I






I I I I







I I I I






ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17

-~J

ATTACHMENT

Chron-1


-~J

ATTACHMENT

Chron-1



lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC


20a SE 3rd S[


VSH t -71 t


0 2068 Ictllfe w(r~

9J3f~OOU 23oi





I I t I

M1 SN

Site Location

Maftufacturu Oa~Q





9f102000 662




I I I I

VfSN

sac LccLltlon




C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

55

fSIb2000 ActPo-eCYC

)wn01V Cc lt41



1212912008 154 ~ 135


1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate



i4~lt ~

__ rl~fj ~

l~F7 ~

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612 ~OOI 11lZOOB -f -4~










I I I I I






I I I I







I I I I






ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17


lgtlTSW

Sitcc LCJtM

Maflqf1tturlllOlC


20a SE 3rd S[


VSH t -71 t


0 2068 Ictllfe w(r~

9J3f~OOU 23oi





I I t I

M1 SN

Site Location

Maftufacturu Oa~Q





9f102000 662




I I I I

VfSN

sac LccLltlon




C~f _

i~l07 wt1ft~r J I

1I6i2oo3 10~ 10i

31120lt8 773

55

fSIb2000 ActPo-eCYC

)wn01V Cc lt41



1212912008 154 ~ 135


1213112008

I I I I

hUSH

Silo lQcatiQ1

ManifnCUHCDate



i4~lt ~

__ rl~fj ~

l~F7 ~

t~H)1

mJ2(ID8 r -~~~7

612 ~OOI 11lZOOB -f -4~










I I I I I






I I I I







I I I I






ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17

ATTACHMENT

INTERTEK 1


ATTACHMENT

INTERTEK 1











2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17










2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17


2


2



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17



3



3




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17




R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17


R11400


5


R11400


5




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17




6




6

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17

7 7

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17

9 9




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17




10




10


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17


11


11



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17



J3



J3

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17

14 14



J5



J 5


16


16



In conclusion


17



In conclusion



17



J5



J 5


16


16



In conclusion


17



In conclusion



17


16


16



In conclusion


17



In conclusion



17



In conclusion


17



In conclusion



17

Documents

12 b. This information was originally contained in the ...12 b. This information was originally contained in the February 13, 2009 submittal as: ATTACHMENT - Chron - 1 · , Withhold