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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.
Definition Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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 19
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 9
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 11
DEROYAL
  SUBSTANTIALLY EQUIVALENT 3
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 and 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 2
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 1490
Detachment of device component 1017
Inflation issue 608
Material fragmentation 536
Leak 294
Air leak 285
Gas leak 202
Optical distortion 182
Detachment of device or device component 176
Replace 174
No Known Device Problem 167
Material separation 156
Tears, rips, holes in device, device material 143
Device operates differently than expected 138
Burst 133
Device packaging compromised 130
Torn material 125
Other (for use when an appropriate device code cannot be identified) 111
Difficult to insert 108
Packaging issue 99
Deployment issue 98
Fracture 95
Image resolution poor 78
Mechanical issue 68
Difficult to remove 65
Device Issue 61
Component falling 59
Material deformation 53
Bent 50
Noise, Audible 48
Dislodged or dislocated 46
Mechanics altered 46
Material perforation 46
Failure to cut 43
No display or display failure 43
Crack 41
Failure to fire 41
Optical issue 38
Tip breakage 37
Unknown (for use when the device problem is not known) 35
Mechanical jam 35
Hole in material 34
Component missing 33
Deflation issue 32
Retraction problem 32
Use of Device Issue 31
Electrical issue 29
Component(s), broken 28
Failure to Adhere or Bond 28
Physical resistance 26
Burn of device or device component 25
Failure to deploy 25
Device, or device fragments remain in patient 25
Misfire 24
Human-Device Interface Issue 24
No Information 23
Failure to form staple 23
Tear, rip or hole in device packaging 23
Device inoperable 22
Fitting problem 22
Spark 21
Material rupture 21
Device maintenance issue 21
Smoking 20
Fluid leak 19
Poor quality image 18
Out-of-box failure 18
Device damaged prior to use 18
Electrical power problem 18
Difficult to open or close 17
Peeled 17
Melted 17
Sticking 17
Device, removal of (non-implant) 16
Device or device fragments location unknown 16
No code available 16
Failure to advance 15
Malfunction 15
Cut in material 15
Erratic display 15
Entrapment of device or device component 13
Image display error 13
Slippage of device or device component 13
Foreign material present in device 13
Material integrity issue 13
Improper device output 12
Valve(s), failure of 12
Dull 12
Split 12
Difficult to advance 12
Size incorrect for patient 12
Decrease in pressure 12
Loose or intermittent connection 12
No device output 12
Product quality issue 11
Balloon burst 11
Difficult to deploy 10
Material puncture 10
Balloon rupture 9
Seal, defective 9
Total Device Problems 8492

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 3
Class III 0 3 0 0 0 0 0 0 0 0 1

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

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