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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, electrosurgical, active, urological
Regulation Description Endoscopic electrosurgical unit and accessories.
Product CodeFAS
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENDOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
GREENWALD SURGICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 3
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MODERN MEDICAL EQUIPMENT MFG., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 2
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 4
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 38
Melted 5
Arcing 4
No Information 3
Tip breakage 3
Material disintegration 3
Detachment of device component 3
Arcing at electrodes 2
Electrode(s), failure of 2
Electrode(s), fracture of 2
Split 2
Device, or device fragments remain in patient 2
Material separation 1
Device or device fragments location unknown 1
Device displays error message 1
Sharp/jagged/rough/etched/scratched 1
Spark 1
Device operates differently than expected 1
Output issue 1
Failure to deliver energy 1
User used incorrect product for intended use 1
Electrical wires, defective 1
Wire(s), breakage of 1
Component incompatible 1
Degraded 1
Disconnection 1
No display or display failure 1
Burn of device or device component 1
Component(s), broken 1
Total Device Problems 86

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