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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, air, non-manual, for endoscope
Regulation Description Endoscope and accessories.
Product CodeFEQ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 3
KEYMED
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fluid leak 1
Inability to irrigate 1
Reflux within device 1
Improper or incorrect procedure or method 1
No Known Device Problem 1
Protective measure issue 1
Total Device Problems 6

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

Recalls
Manufacturer Recall Class Date Posted
1 Olympus America Inc. II Nov-15-2013
2 Olympus America Inc. III Jan-18-2012
3 Olympus Corporation of the Americas II Oct-08-2015

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