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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, non-rigid
Regulation Description Flexible laryngoscope.
Product CodeCAL
Regulation Number 868.5530
Device Class 1


Premarket Reviews
ManufacturerDecision
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Battery issue 8
Deployment issue 5
Device Cleaning Issue 4
Failure to conduct 4
Material fragmentation 3
Difficult to insert 2
Difficult to remove 2
Break 2
Device or device fragments location unknown 2
Tip breakage 1
Inadequate lighting 1
Material deformation 1
Poor quality image 1
Image orientation incorrect 1
No display or display failure 1
Fracture 1
Component(s), broken 1
Detachment of device component 1
Total Device Problems 41

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

Recalls
Manufacturer Recall Class Date Posted
1 Karl Storz Endoscopy America Inc II Dec-17-2013

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