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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
Regulation Description Thermal cautery unit.
Product CodeHQP
Regulation Number 886.4115
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 3
2021 2 2
2022 7 7
2023 8 8
2024 23 23
2025 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 18 18
Fire 11 11
Overheating of Device 4 4
Sparking 3 3
Insufficient Information 3 3
Temperature Problem 3 3
Defective Device 2 2
Failure to Power Up 2 2
Explosion 2 2
Failure to Shut Off 1 1
Mechanical Problem 1 1
Unclear Information 1 1
Battery Problem 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Activation Failure 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1
Self-Activation or Keying 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Discharge 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
Insufficient Information 6 6
Superficial (First Degree) Burn 4 4
Burn(s) 3 3
Laceration(s) 2 2
Eye Burn 1 1
No Consequences Or Impact To Patient 1 1

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