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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device resectoscope
Regulation Description Endoscope and accessories.
Product CodeFJL
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON
  SUBSTANTIALLY EQUIVALENT 2
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 57
Unknown (for use when the device problem is not known) 4
Tip breakage 3
Arcing 3
Locking mechanism failure 2
Device Issue 2
Detachment of device component 2
Component falling 2
Material disintegration 1
Fracture 1
Insulation, hole(s) in 1
Intra-cavity procedure, fiberoptic break or fragmentation during 1
Loose 1
Normal 1
Repair 1
Replace 1
Bent 1
Burn of device or device component 1
Component(s), broken 1
Device damaged prior to use 1
Arcing at electrodes 1
Implant, removal of 1
Detachment of device or device component 1
Device operates differently than expected 1
Device handling issue 1
Total Device Problems 92

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 2 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Karl Storz Endoscopy America Inc II May-11-2013
2 Richard Wolf Medical Instruments Corp. II Nov-04-2013

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