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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device image, illumination, fiberoptic, for endoscope
Regulation Description Endoscope and accessories.
Product CodeFFS
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUTECH
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRUPHATEK INTERNATIONAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Normal 11
Locking mechanism failure 2
Detachment of device component 2
Component falling 2
Component(s), worn 2
Overheating of device or device component 2
System fails to activate 1
Use of Device Issue 1
Device damaged prior to use 1
Burn hole(s) 1
Device Issue 1
Image resolution poor 1
Component(s), overheating of 1
Device emits odor 1
Total Device Problems 29

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 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc Endoscopy Division II Jun-07-2007

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