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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 11
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 927
Detachment of device component 546
Inflation issue 279
Air leak 271
Material fragmentation 241
Leak 200
Optical distortion 182
Replace 174
Gas leak 164
Detachment of device or device component 155
Tears, rips, holes in device, device material 143
Material separation 133
No Known Device Problem 124
Device operates differently than expected 115
Burst 114
Other (for use when an appropriate device code cannot be identified) 111
Torn material 87
Image resolution poor 77
Difficult to insert 63
Device Issue 60
Component falling 53
Fracture 53
Deployment issue 51
Mechanical issue 48
Dislodged or dislocated 45
Crack 40
Failure to cut 39
Tip breakage 37
Bent 35
Difficult to remove 34
Unknown (for use when the device problem is not known) 34
Component missing 31
Optical issue 31
Use of Device Issue 30
Device packaging compromised 29
Electrical issue 29
Component(s), broken 28
Device, or device fragments remain in patient 25
Retraction problem 25
Noise, Audible 24
Burn of device or device component 23
Device inoperable 22
Material perforation 22
Fitting problem 22
No Information 21
Device maintenance issue 21
Deflation issue 19
Packaging issue 19
Tear, rip or hole in device packaging 19
Out-of-box failure 18
Electrical power problem 18
Device damaged prior to use 17
Fluid leak 17
Poor quality image 17
Hole in material 17
Smoking 17
Sticking 16
Failure to deploy 16
Device or device fragments location unknown 16
Device, removal of (non-implant) 16
Malfunction 15
Mechanical jam 15
No display or display failure 15
Material rupture 15
Peeled 14
Material deformation 14
Failure to form staple 14
Difficult to open or close 13
Cut in material 13
No code available 13
Material integrity issue 12
Valve(s), failure of 12
Split 12
Image display error 12
Loose or intermittent connection 12
Size incorrect for patient 12
Decrease in pressure 12
Slippage of device or device component 11
Melted 11
Balloon burst 11
Misfire 11
Dull 11
Difficult to advance 11
Spark 11
Improper device output 11
Physical resistance 10
Failure to advance 9
Seal, defective 9
Balloon rupture 9
Material puncture 9
Foreign material 8
Particulates 8
Normal 8
False device output 8
Connection issue 8
Device or device component damaged by another device 8
Foreign material present in device 8
Human-Device Interface Issue 7
Defective component 7
Failure to deliver energy 7
Total Device Problems 5696

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 1 0
Class II 2 4 2 8 10 2 5 7 3 5 0
Class III 0 3 0 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 Banyan Medical, LLC II Oct-13-2016
9 CTS, Inc. dba Guidant Cardiac Surgery II Dec-13-2010
10 CTS, Inc. dba Guidant Cardiac Surgery II Dec-23-2008
11 Carefusion 2200 Inc I Jul-22-2016
12 Conmed Corporation II Feb-02-2008
13 Conmed Corporation II Mar-13-2007
14 Continental Medical Labs,Inc II Jan-18-2007
15 Covidien LP II Jun-05-2013
16 Davol, Inc., Subs. C. R. Bard, Inc. II Jun-02-2014
17 DeRoyal Industries Inc II May-21-2015
18 EXP Pharmaceutical Services Corp II Jul-24-2015
19 Endoplus, Inc. II Sep-21-2013
20 Ethicon Endo-Surgery Inc II Jul-19-2013
21 Ethicon Endo-Surgery Inc II Jan-27-2009
22 Gyrus Acmi, Incorporated II Sep-19-2010
23 Intuitive Surgical, Inc. II Dec-19-2014
24 Karl Storz Endoscopy America Inc II Dec-06-2013
25 Lumenis II Sep-16-2015
26 Lumenis Limited I Feb-14-2013
27 Novadaq Technologies Inc. II Mar-02-2016
28 Olympus America Inc. II Oct-01-2010
29 Pentax Medical Company II Jul-23-2016
30 Pentax Medical Company II Jun-28-2016
31 Smith & Nephew, Inc. Endoscopy Division II May-01-2012
32 Smith & Nephew, Inc. Endoscopy Division II Oct-21-2011
33 Stryker Communications III Jan-12-2008
34 Stryker Communications Corp II Oct-28-2011
35 Stryker Communications Corp II Jun-15-2010
36 Stryker Communications Corp II May-21-2010
37 Stryker Communications Corp III Sep-29-2008
38 Stryker Endoscopy II Dec-12-2014
39 Stryker Endoscopy II Jan-19-2011
40 Stryker Endoscopy II Sep-29-2010
41 Stryker Endoscopy III Oct-24-2008
42 Stryker Endoscopy II Aug-24-2008
43 Teleflex Medical II Oct-07-2016
44 Teleflex Medical II Apr-02-2014
45 Teleflex Medical II Mar-25-2014
46 Teleflex Medical II Jun-23-2010
47 Terumo Cardiovascular Systems Corporation II Feb-21-2014
48 Terumo Cardiovascular Systems Corporation II Jul-21-2011
49 Terumo Cardiovascular Systems Corporation II Feb-14-2011
50 Transenterix, INC II Sep-22-2010
51 Transenterix, Inc II Aug-03-2012
52 Transenterix, Inc II Apr-08-2011
53 Xlumena, Inc. II Sep-09-2013

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