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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
Bacterial contamination of device 20
Device Cleaning Issue 18
No Known Device Problem 14
Disinfection or Sterilization Issue at User Location 8
Device operates differently than expected 6
Break 6
Foreign material present in device 5
Device Contamination with biological material 4
Electro-static discharge 4
Material fragmentation 4
Contamination during use 3
Residue after decontamination 3
Material deformation 3
Maintenance does not comply to manufacturers recommendations 2
Difficult to remove 2
Failure to flush 2
Obstruction within device 1
Sharp/jagged/rough/etched/scratched 1
Degraded 1
Material disintegration 1
No display or display failure 1
Incorrect display 1
Entrapment of device or device component 1
Excess flow or overinfusion 1
Poor quality image 1
Increase in pressure 1
Inadequate lighting 1
Installation-related problem 1
Device disinfection or sterilization issue 1
Device or device component damaged by another device 1
Output issue 1
No Information 1
No code available 1
Total Device Problems 121

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