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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
2021 10 10
2022 1 1
2023 9 9
2024 29 29
2025 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Break 47 47
Detachment of Device or Device Component 25 25
Material Fragmentation 14 14
Fracture 10 10
Mechanical Problem 8 8
Failure to Cut 5 5
Material Separation 4 4
Arcing 4 4
Insufficient Information 3 3
Excessive Heating 3 3
Flare or Flash 2 2
Explosion 2 2
Sparking 1 1
Crack 1 1
Appropriate Term/Code Not Available 1 1
Overheating of Device 1 1
Arcing of Electrodes 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
Insufficient Information 21 21
Foreign Body In Patient 13 13
Superficial (First Degree) Burn 4 4
Burn(s) 3 3
Uterine Perforation 2 2
Convulsion/Seizure 2 2
Unspecified Infection 1 1
Abnormal Blood Gases 1 1
Swelling/ Edema 1 1
No Consequences Or Impact To Patient 1 1

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