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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gastroscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To examine or perform procedures in the stomach.
Product CodeFDS
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJI
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 8
PENTAX
  SUBSTANTIALLY EQUIVALENT 8
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Cleaning Issue 62
Bacterial contamination of device 39
No display or display failure 36
No Known Device Problem 21
Disinfection or Sterilization Issue at User Location 10
Break 8
Foreign material present in device 6
No Information 6
Connection issue 5
Device Issue 5
Misconnection 5
Overheating of device or device component 4
Obstruction within device 4
Mechanical jam 4
Use of Device Issue 3
Improper or incorrect procedure or method 3
Sticking 3
Fluid leak 3
Difficult to insert 3
Contamination during use 3
Device clogged 2
Blockage within device or device component 2
Material fragmentation 2
Mechanical issue 2
Leak 2
Device damaged prior to use 2
Defective component 2
Device Contamination with biological material 2
No code available 2
Scratched material 1
Temperature issue 1
Not Applicable 1
Difficult to open or close 1
Dislodged or dislocated 1
Infusion or flow issue 1
Maintenance does not comply to manufacturers recommendations 1
Material integrity issue 1
Cut in material 1
Failure to advance 1
Physical resistance 1
Loose or intermittent connection 1
Device inoperable 1
Poor quality image 1
Difficult to position 1
Decrease in pressure 1
Material puncture 1
Product quality issue 1
Reflux within device 1
Difficult to remove 1
Material rupture 1
Image display error 1
Kinked 1
Incorrect display 1
Electrical issue 1
Fire 1
Accessory incompatible 1
Detachment of device component 1
Crack 1
Decrease in suction 1
Degraded 1
Failure to disinfect 1
Total Device Problems 283

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 1 1 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fujinon Inc II Oct-30-2013
2 Pentax Medical Company II Jun-28-2016
3 Pentax Medical Company II Jul-24-2014
4 Pentax of America Inc II Oct-26-2016

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