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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laparoscope, general & plastic surgery
Regulation Description Endoscope and accessories.
Product CodeGCJ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ACKERMANN INSTRUMENTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 13
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANCHOR PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 3
APPLE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 22
APPLITEC, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROTEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAITELLA AG
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 12
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 4
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPUTER MOTIO
  SUBSTANTIALLY EQUIVALENT 21
CONMED
  SUBSTANTIALLY EQUIVALENT 18
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 9
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 9
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
DESIGN STANDARDS CORP.
  SUBSTANTIALLY EQUIVALENT 1
Eagle
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
ENCISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCONTROL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 49
EZSURGICAL
  SUBSTANTIALLY EQUIVALENT 1
GENICON
  SUBSTANTIALLY EQUIVALENT 5
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 5
HAAKO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
HENKE SASS WOLF
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
I.C. MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INLET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INNOVIA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTERLACE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 9
J. JAMNER
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 52
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 2
KINETIC SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 4
LSI SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MAUNA KEA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MECTRA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDAFOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 5
MEDSYS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
MICROLINE PENTAX, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
MINI LAP TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
NOVADAQ TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOVARE SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVATECH S.A.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 15
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
OPTISCAN PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
OPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 6
PATTON SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 2
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
POINTE CONCEPTION MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 29
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1
SHIPPERT MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 14
SOLOS ENDOSCOPY, INC
  SUBSTANTIALLY EQUIVALENT 1
SOPRO
  SUBSTANTIALLY EQUIVALENT 13
SPEMBLY CRYOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 21
SURGICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGIQUEST, INC.
  SUBSTANTIALLY EQUIVALENT 6
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 4
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
TAUT
  SUBSTANTIALLY EQUIVALENT 5
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
TRANSAMERICAN TECHNOLOGIES INTL.
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
TROKAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  1
  SUBSTANTIALLY EQUIVALENT 36
VIRTUAL PORTS LTD
  SUBSTANTIALLY EQUIVALENT 2
VISIONSENSE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 2
W.O.M. GMBH
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 715
Detachment of device component 430
Air leak 243
Optical distortion 182
Leak 174
Replace 174
Material fragmentation 164
Gas leak 157
Tears, rips, holes in device, device material 143
Inflation issue 133
Material separation 124
Device operates differently than expected 114
Other (for use when an appropriate device code cannot be identified) 111
No Known Device Problem 105
Detachment of device or device component 102
Torn material 85
Burst 83
Image resolution poor 77
Device Issue 60
Component falling 48
Difficult to insert 48
Dislodged or dislocated 45
Mechanical issue 43
Fracture 38
Tip breakage 37
Crack 37
Failure to cut 34
Unknown (for use when the device problem is not known) 34
Use of Device Issue 30
Component missing 29
Bent 29
Component(s), broken 28
Electrical issue 26
Retraction problem 25
Device, or device fragments remain in patient 25
Difficult to remove 22
Device inoperable 22
Optical issue 22
Device packaging compromised 21
Device maintenance issue 21
Burn of device or device component 21
Fitting problem 20
Deployment issue 19
Electrical power problem 18
No Information 18
Out-of-box failure 17
Fluid leak 17
Poor quality image 17
Sticking 16
Failure to deploy 16
Device, removal of (non-implant) 16
Device or device fragments location unknown 15
Device damaged prior to use 15
Tear, rip or hole in device packaging 15
Malfunction 15
Smoking 15
Peeled 14
No display or display failure 13
No code available 13
Mechanical jam 13
Split 12
Material perforation 12
Valve(s), failure of 12
Difficult to open or close 12
Loose or intermittent connection 12
Hole in material 12
Image display error 12
Size incorrect for patient 12
Decrease in pressure 12
Balloon burst 11
Difficult to advance 11
Spark 11
Failure to form staple 11
Material integrity issue 11
Packaging issue 11
Material deformation 10
Dull 10
Material rupture 10
Balloon rupture 9
Seal, defective 9
Improper device output 9
Noise, Audible 9
Foreign material present in device 8
Connection issue 8
Material puncture 8
Slippage of device or device component 8
Foreign material 8
Melted 8
Particulates 8
Normal 8
Failure to deliver energy 7
Failure to advance 7
Misfire 7
Cut in material 7
Device or device component damaged by another device 6
False device output 6
Coagulation in device or device ingredient 6
Loss of or failure to bond 5
Failure to fire 5
Defective item 5
Total Device Problems 4728

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 0 0 1
Class II 2 4 2 8 10 2 5 7 3 3
Class III 0 3 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Anchor Products Company, Inc. II Mar-07-2011
2 Applied Medical Resources Corp II Jan-24-2014
3 Applied Medical Resources Corp II Aug-24-2011
4 Applied Medical Resources Corp II Aug-10-2011
5 Applied Medical Resources Corp II Mar-03-2011
6 Applied Medical Resources Corp II Sep-18-2009
7 Applied Medical Resources Corp II Oct-07-2008
8 CTS, Inc. dba Guidant Cardiac Surgery II Dec-13-2010
9 CTS, Inc. dba Guidant Cardiac Surgery II Dec-23-2008
10 Carefusion 2200 Inc I Jul-22-2016
11 Conmed Corporation II Feb-02-2008
12 Conmed Corporation II Mar-13-2007
13 Continental Medical Labs,Inc II Jan-18-2007
14 Covidien LP II Jun-05-2013
15 Davol, Inc., Subs. C. R. Bard, Inc. II Jun-02-2014
16 DeRoyal Industries Inc II May-21-2015
17 EXP Pharmaceutical Services Corp II Jul-24-2015
18 Endoplus, Inc. II Sep-21-2013
19 Ethicon Endo-Surgery Inc II Jul-19-2013
20 Ethicon Endo-Surgery Inc II Jan-27-2009
21 Gyrus Acmi, Incorporated II Sep-19-2010
22 Intuitive Surgical, Inc. II Dec-19-2014
23 Karl Storz Endoscopy America Inc II Dec-06-2013
24 Lumenis II Sep-16-2015
25 Lumenis Limited I Feb-14-2013
26 Novadaq Technologies Inc. II Mar-02-2016
27 Olympus America Inc. II Oct-01-2010
28 Pentax Medical Company II Jul-23-2016
29 Pentax Medical Company II Jun-28-2016
30 Smith & Nephew, Inc. Endoscopy Division II May-01-2012
31 Smith & Nephew, Inc. Endoscopy Division II Oct-21-2011
32 Stryker Communications III Jan-12-2008
33 Stryker Communications Corp II Oct-28-2011
34 Stryker Communications Corp II Jun-15-2010
35 Stryker Communications Corp II May-21-2010
36 Stryker Communications Corp III Sep-29-2008
37 Stryker Endoscopy II Dec-12-2014
38 Stryker Endoscopy II Jan-19-2011
39 Stryker Endoscopy II Sep-29-2010
40 Stryker Endoscopy III Oct-24-2008
41 Stryker Endoscopy II Aug-24-2008
42 Teleflex Medical II Apr-02-2014
43 Teleflex Medical II Mar-25-2014
44 Teleflex Medical II Jun-23-2010
45 Terumo Cardiovascular Systems Corporation II Feb-21-2014
46 Terumo Cardiovascular Systems Corporation II Jul-21-2011
47 Terumo Cardiovascular Systems Corporation II Feb-14-2011
48 Transenterix, INC II Sep-22-2010
49 Transenterix, Inc II Aug-03-2012
50 Transenterix, Inc II Apr-08-2011
51 Xlumena, Inc. II Sep-09-2013

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