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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, cautery, thermal, ac-powered
Regulation Description Thermal cautery unit.
Product CodeHQO
Regulation Number 886.4115
Device Class 2


Premarket Reviews
ManufacturerDecision
SPEMBLY CRYOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
STARION INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Failure to deliver energy 27
Intermittent continuity 11
Electrical issue 11
No Information 10
Break 6
Loss of power 5
Device remains activated 3
Environmental control or utility issue 3
Component missing 3
Environmental Particulates 2
Smoking 2
Device inoperable 1
Cable, defective 1
Mechanics altered 1
Power source issue 1
Failure to power-up 1
Overheating of device or device component 1
Charred 1
Elective replacement 1
Device operates differently than expected 1
Total Device Problems 92

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