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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope, accessories, narrow band spectrum
Regulation Description Endoscope and accessories.
Definition Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.
Product CodeNWB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Known Device Problem 30
Bacterial contamination of device 29
Device Cleaning Issue 18
Disinfection or Sterilization Issue at User Location 8
Break 7
Device operates differently than expected 6
Foreign material present in device 5
Device Contamination with biological material 4
Material fragmentation 4
Electro-static discharge 4
Contamination during use 3
Residue after decontamination 3
Material deformation 3
Device or device component damaged by another device 2
Failure to flush 2
Maintenance does not comply to manufacturers recommendations 2
Difficult to remove 2
Material disintegration 1
No display or display failure 1
Obstruction within device 1
Degraded 1
No code available 1
Inadequate lighting 1
Increase in pressure 1
No Information 1
Mechanical issue 1
Incorrect display 1
Output issue 1
Entrapment of device or device component 1
Device disinfection or sterilization issue 1
Installation-related problem 1
Excess flow or overinfusion 1
Sharp/jagged/rough/etched/scratched 1
Leak 1
Poor quality image 1
Total Device Problems 150

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