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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, electrosurgical andcoagulation, with accessories
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Product CodeBWA
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 5
Difficult to open or close 3
Sticking 2
Device or device fragments location unknown 2
Spark 1
Metal shedding debris 1
Detachment of device component 1
Crack 1
Material separation 1
No Known Device Problem 1
Scratched material 1
No Information 1
Total Device Problems 20

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