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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, electrosurgical
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Product CodeHAM
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 3
2021 1 1
2023 3 3
2024 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 3 3
Delivered as Unsterile Product 2 2
Break 1 1
Activation Problem 1 1
Material Erosion 1 1
Energy Output Problem 1 1
Defective Component 1 1
Protective Measures Problem 1 1
Melted 1 1
Self-Activation or Keying 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 3 3
Superficial (First Degree) Burn 2 2
No Patient Involvement 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Burn(s) 1 1
No Consequences Or Impact To Patient 1 1

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