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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope, flexible
Regulation Description Endoscope and accessories.
Product CodeGCQ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device Cleaning Issue 17
No display or display failure 4
Bacterial contamination of device 4
Material frayed 3
Leak 2
Cut in material 2
Failure to disinfect 2
No Known Device Problem 2
No Information 1
Break 1
Disinfection or Sterilization Issue at User Location 1
Component or accessory incompatibility 1
Material Protrusion 1
Retraction problem 1
Material perforation 1
Total Device Problems 43

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

Recalls
Manufacturer Recall Class Date Posted
1 Integrated Medical Systems Inc II Feb-25-2016

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