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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 153
No Known Device Problem 133
Device Cleaning Issue 55
Contamination during use 44
Corrosion 19
No Information 15
Disinfection or Sterilization Issue at User Location 10
No display or display failure 6
Break 4
Foreign material present in device 4
Device Issue 3
Design/structure problem 3
Failure to disinfect 2
Obstruction within device 2
Difficult or delayed activation 1
Device displays error message 1
Device Contamination with biological material 1
Difficult to advance 1
Dislodged or dislocated 1
Maintenance does not comply to manufacturers recommendations 1
Residue after decontamination 1
Scratched material 1
Blockage within device or device component 1
Difficult to deploy 1
Material frayed 1
Image resolution poor 1
Loose or intermittent connection 1
Device maintenance issue 1
Poor quality image 1
Retraction problem 1
Device inoperable 1
Metal shedding debris 1
Defective component 1
Total Device Problems 472

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 3 5
Class III 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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