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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device duodenoscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To examine the duodenum and to perform various procedures within the duodenum.
Product CodeFDT
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 3
PENTAX
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Bacterial contamination of device 189
No Known Device Problem 144
Device Cleaning Issue 55
Contamination during use 44
No Information 20
Corrosion 19
Disinfection or Sterilization Issue at User Location 10
Break 10
Device Issue 8
No display or display failure 6
Design/structure problem 5
Foreign material present in device 4
Failure to disinfect 2
Crack 2
Obstruction within device 2
Retraction problem 1
Maintenance does not comply to manufacturers recommendations 1
Dislodged or dislocated 1
Metal shedding debris 1
Material frayed 1
Device displays error message 1
Difficult to deploy 1
Residue after decontamination 1
Material integrity issue 1
Image resolution poor 1
Defective component 1
Device inoperable 1
Difficult to advance 1
Scratched material 1
Difficult or delayed activation 1
Loose or intermittent connection 1
Device clogged 1
Device Contamination with biological material 1
Device maintenance issue 1
Poor quality image 1
Blockage within device or device component 1
Total Device Problems 541

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 3 5 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fujifilm Medical Systems U.S.A., Inc. II May-31-2016
2 Fujifilm Medical Systems U.S.A., Inc. II Dec-15-2015
3 Fujifilm Medical Systems U.S.A., Inc. II Sep-17-2015
4 Olympus America Inc. II Sep-22-2015
5 Olympus Corporation of the Americas II May-31-2016
6 Olympus Corporation of the Americas II Feb-04-2016
7 Pentax Medical Company II Jul-23-2016
8 Pentax Medical Company II May-27-2016

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