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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2021 5 5
2022 8 8
2023 9 9
2024 3 3
2025 6 6
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 18 18
Detachment of Device or Device Component 9 9
Material Fragmentation 7 7
Mechanical Problem 4 4
Material Twisted/Bent 4 4
Fracture 4 4
Insufficient Information 3 3
Material Deformation 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Entrapment of Device 1 1
Partial Blockage 1 1
Device Dislodged or Dislocated 1 1
Excessive Heating 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Insufficient Information 4 4
Burn(s) 2 2
Foreign Body In Patient 2 2
Uterine Perforation 1 1
Pain 1 1
Device Embedded In Tissue or Plaque 1 1

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