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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
2021 2 2
2022 7 7
2023 8 8
2024 23 23
2025 22 22
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Fire 8 8
Failure to Power Up 6 6
Overheating of Device 3 3
Explosion 2 2
Insufficient Device Problem Information 2 2
Temperature Problem 2 2
Sparking 2 2
Intermittent Loss of Power 1 1
Complete Loss of Power 1 1
Unclear Information 1 1
Excessive Heating 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Unexpected Shutdown 1 1
Insufficient Heating 1 1
Detachment of Device or Device Component 1 1
Output below Specifications 1 1
Mechanical Problem 1 1
Failure to Discharge 1 1
Device Remains Activated 1 1
Activation Failure 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
Insufficient Information 6 6
Superficial (First Degree) Burn 4 4
Burn(s) 3 3
Laceration(s) 2 2
Distress 1 1
Eye Burn 1 1
Scar Tissue 1 1
Foreign Body In Patient 1 1
Full thickness (Third Degree) Burn 1 1

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