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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. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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
Loss of or failure to bond 578
Bacterial contamination of device 265
No Known Device Problem 166
Device Cleaning Issue 65
Contamination during use 48
No Information 21
No code available 21
Corrosion 19
Break 16
Disinfection or Sterilization Issue at User Location 13
No display or display failure 11
Device Issue 9
Design/structure problem 5
Foreign material present in device 5
Device Contamination with biological material 3
Obstruction within device 3
Failure to separate 2
Failure to disinfect 2
Device clogged 2
Crack 2
Difficult to deploy 1
Failure 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
Material rigid or stiff 1
Device inoperable 1
Metal shedding debris 1
Defective component 1
Residue after decontamination 1
Difficult or delayed activation 1
Device displays error message 1
Device disinfection or sterilization issue 1
Difficult to advance 1
Dislodged or dislocated 1
Maintenance does not comply to manufacturers recommendations 1
Material integrity issue 1
Scratched material 1
Blockage within device or device component 1
Total Device Problems 1278

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 3
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 Sep-27-2017
2 Fujifilm Medical Systems U.S.A., Inc. II Sep-13-2017
3 Fujifilm Medical Systems U.S.A., Inc. II May-31-2016
4 Fujifilm Medical Systems U.S.A., Inc. II Dec-15-2015
5 Fujifilm Medical Systems U.S.A., Inc. II Sep-17-2015
6 Olympus America Inc. II Sep-22-2015
7 Olympus Corporation of the Americas II May-31-2016
8 Olympus Corporation of the Americas II Feb-04-2016
9 Pentax Medical Company II Jul-23-2016
10 Pentax Medical Company II May-27-2016
11 Pentax of America Inc II Jul-11-2017

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