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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cable, electrode
Regulation Description Electrode cable.
Product CodeIKD
Regulation Number 890.1175
Device Class 2


Premarket Reviews
ManufacturerDecision
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Connection issue 46
Burn of device or device component 6
Cable break 5
Misconnection 2
Device operates differently than expected 2
Break 2
Spark 2
No Known Device Problem 1
Replace 1
Use of Device Issue 1
Electrical wires, defective 1
Failure to capture 1
Failure to deliver energy 1
Total Device Problems 71

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 2 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 St. Jude Medical II Aug-05-2011
2 Sterilmed Inc II Jan-13-2009
3 Vermed, Inc. II May-04-2011

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