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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, electrosurgical
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Product CodeJOS
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
CONMED
  SUBSTANTIALLY EQUIVALENT 1
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MINNTECH
  SUBSTANTIALLY EQUIVALENT 1
RADIOTHERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 24
Peeled 9
Unknown (for use when the device problem is not known) 6
Retraction problem 6
Normal 6
Physical resistance 6
Difficult to insert 3
Biofilm coating in device 3
Failure to deploy 3
Electrical issue 3
Difficult to deploy 2
Difficult to remove 2
Melted 2
Noise 2
Device displays error message 2
Spark 2
Inappropriate shock 2
Device damaged prior to use 2
Component missing 1
Failure to advance 1
Tears, rips, holes in device, device material 1
Twisting 1
Detachment of device or device component 1
No Information 1
Sharp/jagged/rough/etched/scratched 1
Defective item 1
Device or device fragments location unknown 1
Device abrasion from instrument or another object 1
Mislabeled 1
Bent 1
Insulation degradation 1
Electrode(s), failure of 1
Fire 1
Foreign material 1
Haptic(s), bent 1
IV pole, detachment of parts from 1
Break 1
Burn of device or device component 1
Collimator design problem 1
Detachment of device component 1
Total Device Problems 107

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

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Oct-18-2012
2 Sterilmed Inc II Jan-13-2009

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