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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 12
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 50
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 51
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 1
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 13
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 622
Detachment of device component 390
Air leak 225
Optical distortion 182
Replace 174
Leak 170
Gas leak 154
Tears, rips, holes in device, device material 143
Material fragmentation 133
Device operates differently than expected 112
Other (for use when an appropriate device code cannot be identified) 111
Material separation 111
Inflation issue 103
No Known Device Problem 89
Torn material 78
Detachment of device or device component 77
Image resolution poor 77
Burst 76
Device Issue 59
Component falling 48
Dislodged or dislocated 44
Mechanical issue 42
Tip breakage 37
Crack 37
Fracture 35
Unknown (for use when the device problem is not known) 34
Difficult to insert 32
Component missing 29
Component(s), broken 28
Bent 28
Electrical issue 25
Device, or device fragments remain in patient 25
Use of Device Issue 25
Failure to cut 23
Device inoperable 22
Retraction problem 21
Device maintenance issue 21
Burn of device or device component 21
Fitting problem 20
Electrical power problem 18
No Information 18
Out-of-box failure 17
Fluid leak 17
Device, removal of (non-implant) 16
Device or device fragments location unknown 15
Tear, rip or hole in device packaging 15
Malfunction 15
Optical issue 15
Poor quality image 15
Difficult to remove 15
Smoking 15
Sticking 14
Failure to deploy 14
Device damaged prior to use 14
Device packaging compromised 14
Mechanical jam 13
No code available 13
No display or display failure 13
Peeled 13
Size incorrect for patient 12
Decrease in pressure 12
Valve(s), failure of 12
Split 12
Material perforation 11
Difficult to advance 11
Difficult to open or close 11
Deployment issue 11
Failure to form staple 11
Material integrity issue 11
Loose or intermittent connection 11
Image display error 11
Balloon burst 10
Material deformation 10
Spark 10
Seal, defective 9
Balloon rupture 9
Foreign material 8
Melted 8
Normal 8
Material rupture 8
Slippage of device or device component 8
Particulates 8
Improper device output 8
Foreign material present in device 8
Failure to advance 7
Misfire 7
Connection issue 7
Hole in material 7
Failure to deliver energy 7
False device output 6
Coagulation in device or device ingredient 6
Device or device component damaged by another device 6
Failure to fire 5
Defective item 5
Device displays error message 5
Cut in material 5
Structural problem 4
Dull 4
Improper or incorrect procedure or method 4
Defective component 4
Total Device Problems 4319

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

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