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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 16
Device Cleaning Issue 14
No Known Device Problem 13
Break 6
Device operates differently than expected 6
Electro-static discharge 4
Residue after decontamination 3
Contamination during use 3
Disinfection or Sterilization Issue at User Location 3
Material deformation 3
Maintenance does not comply to manufacturers recommendations 2
Failure to flush 2
Material fragmentation 2
Excess flow or overinfusion 1
Poor quality image 1
Increase in pressure 1
Difficult to remove 1
Degraded 1
Material disintegration 1
No display or display failure 1
Incorrect display 1
Entrapment of device or device component 1
Obstruction within device 1
Device or device component damaged by another device 1
Foreign material present in device 1
Inadequate lighting 1
Installation-related problem 1
Device disinfection or sterilization issue 1
Output issue 1
Total Device Problems 93

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