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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, reprocessed
Regulation Description Endoscope and accessories.
Definition The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. This device is indicated for reuse/reprocessing.
Product CodeNLM
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 5
NORTHEAST SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 6
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Leak 160
Break 54
Device operates differently than expected 7
Foreign material present in device 7
Gas leak 4
Material fragmentation 4
No Information 3
Protective measure issue 2
Material integrity issue 2
Improper device output 2
Item contaminated during manufacturing or shipping 2
False device output 2
Fracture 2
Retraction problem 2
Slippage of device or device component 2
Component missing 1
Dull 1
Device or device fragments location unknown 1
Material separation 1
Fail-safe mechanism issue 1
Material frayed 1
Detachment of device component 1
Continuous firing 1
Failure to cycle 1
Manufacturing or shipping issue associated with device 1
No Known Device Problem 1
Positioning Issue 1
Total Device Problems 267

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 1 0 1 0 0 1 0 3 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ascent Healthcare Solutions, Inc. II Sep-19-2008
2 Ascent Healthcare Solutions, Inc. II Feb-08-2007
3 CooperSurgical, Inc. II May-19-2015
4 Ethicon Endo-Surgery Inc II Sep-30-2010
5 Stryker Sustainability Solutions II Aug-27-2015
6 Stryker Sustainability Solutions II Jun-25-2015
7 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

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