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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light source, endoscope, xenon arc
Regulation Description Endoscope and accessories.
Product CodeGCT
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
GIMMI GMBH
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 4
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No display or display failure 16
Device operates differently than expected 11
No Known Device Problem 9
Normal 6
No Information 5
Poor quality image 3
Smoking 2
Inadequate lighting 2
Device displays error message 2
Power source issue 2
Fuse, blown 1
Spark 1
Device handling issue 1
Output issue 1
Device stops intermittently 1
Unexpected therapeutic results 1
Device Issue 1
No device output 1
User used incorrect product for intended use 1
Total Device Problems 67

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

Recalls
Manufacturer Recall Class Date Posted
1 Linvatec Corp. dba ConMed Linvatec II Sep-25-2012

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