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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device choledochoscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition to examine and perform procedures within the bile ducts.
Product CodeFBN
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 6
PENTAX
  SUBSTANTIALLY EQUIVALENT 3
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material Protrusion 47
Detachment of device component 8
No Known Device Problem 3
Break 2
Device Cleaning Issue 1
Torn material 1
No Information 1
Leak 1
Normal 1
Peeled 1
Difficult to remove 1
Retraction problem 1
Material separation 1
Material perforation 1
Locking mechanism failure 1
Disinfection or Sterilization Issue at User Location 1
Device disinfection or sterilization issue 1
Device packaging compromised 1
Total Device Problems 74

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

Recalls
Manufacturer Recall Class Date Posted
1 Pentax Medical Company II Jun-28-2016

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