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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device generator, lesion, radiofrequency
Regulation Description Radiofrequency lesion generator.
Product CodeGXD
Regulation Number 882.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOFORM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RITA MEDICAL SYSTEMS
  SE - WITH LIMITATIONS 1
STOCKERT GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 32
Temperature issue 21
Device displays error message 21
Device operates differently than expected 15
Failure to shut off 11
Smoking 6
No Information 5
Impedance issue 4
Improper or incorrect procedure or method 4
Electrical issue 4
High impedance 3
Mechanical issue 3
No display or display failure 3
Device remains activated 3
Spark 3
Self-activation or keying 3
Device inoperable 3
Therapeutic or diagnostic output failure 3
No code available 2
Failure to read input signal 2
Use of Device Issue 2
Device sensing issue 2
Unknown (for use when the device problem is not known) 2
Unable to obtain readings 2
Loose or intermittent connection 2
Material frayed 2
Grounding malfunction 1
Fluid leak 1
Break 1
Burn of device or device component 1
Erratic display 1
Device, or device fragments remain in patient 1
No device output 1
Failure to power-up 1
Device Difficult to Setup or Prepare 1
Arcing 1
Other (for use when an appropriate device code cannot be identified) 1
Electrical shorting 1
Wrinkled 1
Inappropriate shock 1
Sticking 1
Device stops intermittently 1
Tip breakage 1
Positioning Issue 1
Power source issue 1
Improper device output 1
Human-Device Interface Issue 1
Total Device Problems 184

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

Recalls
Manufacturer Recall Class Date Posted
1 Neurotherm, Inc. II Apr-09-2016
2 Stryker Instruments Div. of Stryker Corporation II Jan-18-2011

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