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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
Break 44
Optical issue 40
Detachment of device or device component 27
Torn material 21
Material separation 12
Detachment of device component 11
Failure to conduct 11
Material rupture 9
Charging issue 5
Difficult to remove 4
Difficult to open or close 4
Hole in material 3
Failure to separate 2
Fitting problem 2
Device markings issue 2
Mechanical issue 2
Connection issue 2
Device Cleaning Issue 2
Burst 2
Power source issue 1
Improper or incorrect procedure or method 1
No Known Device Problem 1
Material puncture 1
Component missing 1
Failure to charge 1
Crack 1
Device or device fragments location unknown 1
No Information 1
Material perforation 1
Device damaged prior to use 1
Material deformation 1
Material fragmentation 1
Out-of-box failure 1
Total Device Problems 219

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 1 0 0
Class III 0 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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