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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, ablation, microwave and accessories
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Product CodeNEY
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
BSD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
FOUNDRY NEWCO X, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2
H.S. HOSPITAL SERVICES S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDWAVE, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROSULIS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
Miramar Labs, Inc.
  SUBSTANTIALLY EQUIVALENT 1
NEUWAVE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 3
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 22
Device displays error message 8
Bent 8
Temperature issue 7
Device operates differently than expected 5
Buckled material 2
Difficult to insert 2
Break 2
Burn of device or device component 2
Material separation 2
Device inoperable 1
Other (for use when an appropriate device code cannot be identified) 1
Failure to deliver 1
Dull 1
Component(s), broken 1
Detachment of device component 1
Electrical issue 1
Material fragmentation 1
Overheating of device or device component 1
Failure to reset 1
No flow 1
No Known Device Problem 1
Total Device Problems 72

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

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Medical Products (Shanghai) Manufacturing L.L.C. II Mar-17-2016

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