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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
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
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 5
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 119
Melted 8
Arcing at electrodes 8
Burn of device or device component 7
Detachment of device component 7
Spark 6
Arcing 5
Material separation 5
Charred 4
Electrode(s), failure of 4
Material disintegration 4
No Information 4
Tip breakage 3
Split 3
Component missing 2
System fails to activate 2
Device, or device fragments remain in patient 2
Fracture 2
Electrode(s), fracture of 2
Component falling 2
Temperature issue 2
Material deformation 2
No Known Device Problem 2
Device or device fragments location unknown 2
Device operates differently than expected 2
Electrical shorting 2
Foreign material present in device 1
Device or device component damaged by another device 1
Device displays error message 1
Sharp/jagged/rough/etched/scratched 1
Failure to cut 1
Output issue 1
Mechanical jam 1
Mechanics altered 1
Device handling issue 1
Component incompatible 1
Degraded 1
Disconnection 1
Device Cleaning Issue 1
Component(s), broken 1
Failure to deliver energy 1
Entrapment of device or device component 1
Fire 1
Flaked 1
Material fragmentation 1
Hole in material 1
No display or display failure 1
Replace 1
Overheating of device or device component 1
User used incorrect product for intended use 1
Product quality issue 1
Wire(s), breakage of 1
Failure to separate 1
Use of Device Issue 1
Electrical wires, defective 1
Total Device Problems 240

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