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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coagulator-cutter, endoscopic, bipolar (and accessories)
Product CodeHIN
Regulation Number 884.4150
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 9 9
2021 10 10
2022 1 1
2023 9 9
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 21 21
Fracture 8 8
Mechanical Problem 7 7
Material Fragmentation 6 6
Material Separation 3 3
Failure to Cut 2 2
Detachment of Device or Device Component 2 2
Flare or Flash 2 2
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Excessive Heating 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 10 10
No Clinical Signs, Symptoms or Conditions 10 10
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 5 5
Foreign Body In Patient 3 3
Burn(s) 1 1
Fibrosis 1 1

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