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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 55
No display or display failure 33
Bacterial contamination of device 32
No Known Device Problem 20
Disinfection or Sterilization Issue at User Location 8
Break 8
No Information 6
Connection issue 5
Device Issue 5
Misconnection 5
Foreign material present in device 4
Mechanical jam 4
Sticking 3
Use of Device Issue 3
Improper or incorrect procedure or method 3
Overheating of device or device component 3
Difficult to insert 3
Contamination during use 3
Blockage within device or device component 2
Mechanical issue 2
Fluid leak 2
Material fragmentation 2
Device damaged prior to use 2
Defective component 2
No code available 2
Obstruction within device 2
Device Contamination with biological material 2
Dislodged or dislocated 1
Cut in material 1
Failure to advance 1
Physical resistance 1
Scratched material 1
Not Applicable 1
Infusion or flow issue 1
Maintenance does not comply to manufacturers recommendations 1
Material integrity issue 1
Device inoperable 1
Poor quality image 1
Image display error 1
Difficult to position 1
Decrease in pressure 1
Material puncture 1
Reflux within device 1
Difficult to remove 1
Material rupture 1
Accessory incompatible 1
Device clogged 1
Detachment of device component 1
Crack 1
Decrease in suction 1
Degraded 1
Failure to disinfect 1
Kinked 1
Leak 1
Loose or intermittent connection 1
Incorrect display 1
Electrical issue 1
Fire 1
Total Device Problems 252

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 1 1 0 1
Class III 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

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