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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, electrosurgical, endoscopic (with or without accessories)
Regulation Description Endoscopic electrosurgical unit and accessories.
Product CodeKNS
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
APOLLO CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARGOMED
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 15
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
CAMERON-MILLER, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
EMCISION, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 4
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 5
REDFIELD CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
VIDAMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 9

Device Problems
Break 471
Failure to align 357
Other (for use when an appropriate device code cannot be identified) 323
Failure to deliver energy 299
Retraction problem 209
Electrical issue 182
Bent 139
Component(s), broken 133
Wire(s), breakage of 129
Material separation 108
Peeled 95
Detachment of device component 92
No code available 87
Failure to cut 81
Tip breakage 77
Output issue 74
Kinked 72
Cautery 69
Split 68
No Known Device Problem 60
Melted 47
Device inoperable 45
Failure to conduct 45
Material frayed 45
Device displays error message 44
Detachment of device or device component 44
Twisting 43
Pumping issue 32
Failure, intermittent 30
Loose or intermittent connection 29
No device output 29
Unknown (for use when the device problem is not known) 28
Failure to advance 27
Crack 25
Output energy incorrect 23
Device operates differently than expected 23
Device damaged prior to use 22
Heat, failure to 21
Device Issue 20
Fracture 19
Torn material 17
Malfunction 15
Improper or incorrect procedure or method 15
Not audible alarm 14
Material Protrusion 14
Material twisted 14
Arcing 13
Device alarm system issue 13
Tears, rips, holes in device, device material 13
Device, or device fragments remain in patient 13
Source, detachment from 12
Failure to deploy 12
Defective item 12
Handpiece break 11
Flaked 11
Energy output to patient tissue incorrect 10
Difficult to remove 10
Output, low 10
Migration of device or device component 10
No Information 10
Normal 9
Low audible alarm 8
Difficult to deploy 7
Inability to irrigate 7
Endoscopic accessory fire or melt 7
Use of Device Issue 7
Foreign material present in device 7
Physical resistance 7
Spark 7
Defective component 7
Out-of-box failure 6
Dislodged or dislocated 6
Smoking 6
Needle, separation 6
Leak 6
Failure to power-up 6
Probe failure 6
Failure to pump 6
Pumping stopped 6
Difficult to insert 6
Material fragmentation 5
Footswitch failure 5
Shock, electrical 5
Fire 5
Unintended movement 5
Device handling issue 5
Fitting problem 5
Sharp/jagged/rough/etched/scratched 5
Cable, defective 4
Positioning Issue 4
Incorrect display 4
Drift 4
Insulation, hole(s) in 4
Cable break 4
Difficult to position 4
Loss of power 4
Needle, unsheathed 4
Material perforation 4
Decreased pump speed 4
Device Difficult to Setup or Prepare 3
Total Device Problems 4235

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 1 0 3 0 0 1 1 0 0 0
Class III 0 0 2 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Feb-13-2009
2 Cook Endoscopy III Jul-21-2009
3 Cook Endoscopy III Mar-10-2009
4 Cook Endoscopy II Jan-05-2009
5 Gyrus ACMI Corporation II Mar-13-2007
6 Medtronic Neuromodulation II Mar-10-2009
7 Olympus America Inc. II May-08-2013
8 Olympus America Inc. II Jan-20-2012

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