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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, battery-powered
Product CodeHQP
Regulation Number 886.4115
Device Class 2


Premarket Reviews
ManufacturerDecision
BOVIE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FIAB SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2018 3 3
2019 2 2
2020 3 3
2021 2 2
2022 7 7
2023 8 8
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 11 11
Temperature Problem 3 3
Break 2 2
Defective Device 2 2
Insufficient Information 2 2
Sparking 1 1
Battery Problem 1 1
Detachment of Device or Device Component 1 1
Device Disinfection Or Sterilization Issue 1 1
Failure to Shut Off 1 1
Failure to Discharge 1 1
No Apparent Adverse Event 1 1
Mechanical Problem 1 1
Melted 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Self-Activation or Keying 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Insufficient Information 5 5
No Known Impact Or Consequence To Patient 3 3
Burn(s) 3 3
No Consequences Or Impact To Patient 2 2
Burn, Thermal 2 2
Superficial (First Degree) Burn 2 2
No Information 1 1
No Patient Involvement 1 1
Eye Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beaver Visitec II Sep-13-2018
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