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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device snare, flexible
Regulation Description Endoscopic electrosurgical unit and accessories.
Product CodeFDI
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 204
Break 156
Failure to cut 135
Other (for use when an appropriate device code cannot be identified) 87
Failure to deliver energy 78
Component(s), broken 59
Wire(s), breakage of 44
Retraction problem 33
Entrapment of device or device component 30
Electrical issue 28
Bent 26
Cautery 25
No code available 21
No Known Device Problem 18
Melted 16
Kinked 14
Device damaged prior to use 11
Split 11
Close, difficult to 10
Failure to advance 8
Unknown (for use when the device problem is not known) 8
Device inoperable 8
Failure to align 7
Foreign material present in device 7
Torn material 7
Spark 6
Device operates differently than expected 6
Difficult to remove 6
Material separation 6
Fracture 6
Balloon rupture 5
Burn of device or device component 5
No Information 5
Defective item 4
Failure to conduct 4
Material frayed 4
Mechanical issue 4
Normal 4
Twisting 4
Overheating of device or device component 3
Handpiece break 3
Inflation issue 3
Device Issue 3
Detachment of device or device component 3
Connection issue 2
Component missing 2
Malfunction 2
Arcing 2
Heat, failure to 2
Insufficient heating 2
Shock, electrical 2
Energy output to patient tissue incorrect 2
Device expiration issue 2
Crack 2
Unsealed device packaging 2
Knotted 2
Loose or intermittent connection 2
Loose 2
Tears, rips, holes in device, device material 2
Inappropriate shock 2
Source, detachment from 1
Sterility 1
Stretched 1
Tip breakage 1
Unit inactivated 1
Unraveled material 1
Metal shedding debris 1
Noise 1
Material perforation 1
Seal, defective 1
Device maintenance issue 1
Leak 1
Performance 1
Device, or device fragments remain in patient 1
Output energy incorrect 1
Failure to service 1
Shaft break 1
Application interface becomes non-functional or program exits abnormally 1
Difficult to deploy 1
Disassembly 1
Disconnection 1
Dislodged 1
Connection error 1
Contamination during use 1
Component incompatible 1
Blockage within device or device component 1
Loss of or failure to bond 1
Charred 1
Foreign material 1
Electrode(s), failure of 1
Intraprocedure, fire or flash during 1
Heat 1
Material fragmentation 1
Tear, rip or hole in device packaging 1
Device, removal of (non-implant) 1
Difficult to advance 1
Difficult to open or close 1
Extrusion 1
Output issue 1
Total Device Problems 1206

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

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jun-21-2012
2 Olympus America Inc. II Aug-18-2010
3 US Endoscopy Group Inc II Oct-01-2015

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