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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
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 3
PENTAX
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Known Device Problem 101
Bacterial contamination of device 92
Device Cleaning Issue 52
Contamination during use 39
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
Design/structure problem 3
Device Issue 3
Failure to disinfect 2
Obstruction within device 2
Dislodged or dislocated 1
Maintenance does not comply to manufacturers recommendations 1
Retraction problem 1
Metal shedding debris 1
Difficult to deploy 1
Material frayed 1
Residue after decontamination 1
Device displays error message 1
Image resolution poor 1
Device inoperable 1
Defective component 1
Blockage within device or device component 1
Device maintenance issue 1
Poor quality image 1
Device Contamination with biological material 1
Loose or intermittent connection 1
Difficult or delayed activation 1
Difficult to advance 1
Scratched material 1
Total Device Problems 371

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 1
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 Dec-15-2015
2 Fujifilm Medical Systems U.S.A., Inc. II Sep-17-2015
3 Olympus America Inc. II Sep-22-2015
4 Olympus Corporation of the Americas II Feb-04-2016

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