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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 39
Bacterial contamination of device 29
Device Cleaning Issue 14
Break 8
Disinfection or Sterilization Issue at User Location 8
Device operates differently than expected 8
Foreign material present in device 5
Device Contamination with biological material 4
Electro-static discharge 4
Material fragmentation 4
Material deformation 4
Contamination during use 3
Residue after decontamination 3
Difficult to remove 2
Failure to flush 2
Device or device component damaged by another device 2
Detachment of device component 2
No display or display failure 2
Material Protrusion 2
Maintenance does not comply to manufacturers recommendations 2
Output issue 1
No Information 1
No code available 1
Incorrect display 1
Entrapment of device or device component 1
False device output 1
Degraded 1
Material disintegration 1
Excess flow or overinfusion 1
Difficult to insert 1
Kinked 1
Leak 1
Mechanical issue 1
Poor quality image 1
Increase in pressure 1
Device disinfection or sterilization issue 1
Improper device output 1
Inadequate lighting 1
Installation-related problem 1
Obstruction within device 1
Sharp/jagged/rough/etched/scratched 1
Total Device Problems 168

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

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Feb-24-2017

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