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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, endoscope
Regulation Description Endoscope and accessories.
Product CodeGCI
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
COMPUTER MOTIO
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 2
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Optical issue 40
Break 37
Detachment of device or device component 24
Torn material 21
Failure to conduct 11
Material separation 10
Detachment of device component 5
Charging issue 5
Difficult to remove 4
Material rupture 2
Fitting problem 2
Device Cleaning Issue 2
Burst 2
Connection issue 2
Failure to separate 2
Device markings issue 2
Difficult to open or close 2
Mechanical issue 2
Power source issue 1
Material deformation 1
No Known Device Problem 1
Device or device fragments location unknown 1
Failure to charge 1
Crack 1
Material fragmentation 1
Hole in material 1
Material perforation 1
Device damaged prior to use 1
Component missing 1
Out-of-box failure 1
Improper or incorrect procedure or method 1
Total Device Problems 188

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

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015

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