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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 52
Optical issue 40
Torn material 35
Detachment of device or device component 28
Detachment of device component 25
Material rupture 12
Material separation 12
Failure to conduct 11
Difficult to remove 5
Charging issue 5
Difficult to open or close 5
Hole in material 3
Burst 2
Device Cleaning Issue 2
Mechanical issue 2
Fitting problem 2
Material perforation 2
Connection issue 2
Device markings issue 2
Failure to separate 2
Device or device fragments location unknown 1
Improper or incorrect procedure or method 1
Material deformation 1
No Known Device Problem 1
Power source issue 1
No Information 1
Device damaged prior to use 1
Component missing 1
Out-of-box failure 1
Material puncture 1
Failure to charge 1
Difficult to insert 1
Crack 1
Material fragmentation 1
Total Device Problems 263

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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