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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)
Regulation Description Bipolar endoscopic coagulator-cutter and accessories.
Product CodeHIN
Regulation Number 884.4150
Device Class 2

MDR Year MDR Reports MDR Events
2020 9 9
2021 10 10
2022 1 1
2023 9 9
2024 29 29
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 51 51
Detachment of Device or Device Component 23 23
Material Fragmentation 14 14
Fracture 9 9
Mechanical Problem 8 8
Material Separation 6 6
Failure to Cut 5 5
Arcing 4 4
Insufficient Information 3 3
Excessive Heating 3 3
Flare or Flash 2 2
Crack 1 1
Failure to Seal 1 1
Overheating of Device 1 1
Defective Component 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
Arcing of Electrodes 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
Insufficient Information 23 23
Foreign Body In Patient 13 13
No Known Impact Or Consequence To Patient 4 4
Superficial (First Degree) Burn 4 4
Convulsion/Seizure 2 2
No Consequences Or Impact To Patient 2 2
Uterine Perforation 2 2
Swelling/ Edema 1 1
Fibrosis 1 1
Unspecified Infection 1 1
Burn(s) 1 1
Abnormal Blood Gases 1 1

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