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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Product CodeNUJ
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
NORTHEAST SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 7
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Difficult to open or close 63
Device operates differently than expected 22
Failure to cut 13
Break 9
Energy output to patient tissue incorrect 7
Sticking 6
Self-activation or keying 4
No Information 3
No Known Device Problem 3
Failure to auto stop 2
Failure to fire 2
Slippage of device or device component 2
Electrical issue 2
Material fragmentation 2
Mechanical issue 2
Charred 2
Detachment of device component 1
Intermittent continuity 1
Continuous firing 1
Peeled 1
Failure to power-up 1
Material puncture 1
Bent 1
Device inoperable 1
Arcing at electrodes 1
Failure to align 1
Material deformation 1
Material integrity issue 1
Mechanical jam 1
Output issue 1
Protective measure issue 1
Temperature issue 1
Total Device Problems 160

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 STERILMED, INC. II May-31-2016
2 Sterilmed Inc II Jan-13-2009

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