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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laparoscope, gynecologic (and accessories)
Regulation Description Gynecologic laparoscope and accessories.
Product CodeHET
Regulation Number 884.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 7
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CHIRURGISCHE INSTRUMENTE
  SUBSTANTIALLY EQUIVALENT 3
CONCEPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 11
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 15
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
GUNTER BISSINGER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 30
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MILTEX
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 10
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 9
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
TROKAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 9
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 1585
No code available 159
Break 50
Material perforation 20
Detachment of device component 17
No Known Device Problem 9
Failure to cut 7
Material fragmentation 6
Electrical issue 5
Unknown (for use when the device problem is not known) 5
Torn material 5
Dull 4
Device, or device fragments remain in patient 4
Leak 4
Fluid leak 3
Material separation 3
Overheating of device or device component 3
Peeled 3
Use of Device Issue 3
Detachment of device or device component 3
Device operates differently than expected 2
Device displays error message 2
Malfunction 2
Physical resistance 2
Output issue 2
Improper device output 2
No Information 2
Out-of-box failure 2
Loss of power 2
Motor failure 2
System fails to activate 2
Tears, rips, holes in device, device material 2
Tip breakage 2
False device output 2
Component(s), overheating of 2
Burn of device or device component 2
Component(s), broken 1
Component falling 1
Decrease in suction 1
Fracture 1
Hole in material 1
Melted 1
Migration of device or device component 1
Misassembled 1
Smoking 1
Motor drive unit (MDU) stalled or jammed 1
Normal 1
Tear, rip or hole in device packaging 1
Component missing 1
Suction issue 1
Item contaminated during manufacturing or shipping 1
Material deformation 1
Material integrity issue 1
Mechanical jam 1
Misassembled by Users 1
Bent 1
Failure to align 1
Spark 1
Difficult to open or close 1
Total Device Problems 1953

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 1 0 0 0 0 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Oct-07-2008
2 Ethicon, Inc. II Nov-10-2009
3 Market-Tiers Inc II Aug-02-2014
4 Olympus Corporation of the Americas II Dec-10-2015

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