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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 44
Bacterial contamination of device 36
No Information 19
Device Cleaning Issue 14
Break 11
Disinfection or Sterilization Issue at User Location 9
No code available 9
Device operates differently than expected 8
No display or display failure 5
Foreign material present in device 5
Electro-static discharge 4
Material deformation 4
Material fragmentation 4
Erratic display 4
Device Contamination with biological material 4
Difficult to remove 3
Residue after decontamination 3
Detachment of device component 3
Contamination during use 3
Incorrect display 2
Loose or intermittent connection 2
Mechanical issue 2
Poor quality image 2
No device output 2
Failure to flush 2
Device or device component damaged by another device 2
Material Protrusion 2
Maintenance does not comply to manufacturers recommendations 2
Improper device output 1
Inadequate lighting 1
Installation-related problem 1
Output issue 1
Fail-safe mechanism issue 1
Device disinfection or sterilization issue 1
Connection issue 1
Detachment of device or device component 1
Difficult to position 1
Increase in pressure 1
Obstruction within device 1
Sharp/jagged/rough/etched/scratched 1
Buckled material 1
Entrapment of device or device component 1
False device output 1
Excess flow or overinfusion 1
Difficult to insert 1
Kinked 1
Leak 1
Degraded 1
Material disintegration 1
Collapse 1
Total Device Problems 232

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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