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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
2020 12 12
2021 5 5
2022 8 8
2023 9 9
2024 3 3
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 17
Material Fragmentation 7 7
Mechanical Problem 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Detachment of Device or Device Component 4 4
Fracture 4 4
Insufficient Information 3 3
Material Twisted/Bent 2 2
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Entrapment of Device 1 1
High impedance 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Rupture 1 1
Partial Blockage 1 1
Material Separation 1 1
Device Dislodged or Dislocated 1 1
Excessive Heating 1 1
Melted 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Insufficient Information 7 7
No Consequences Or Impact To Patient 4 4
Burn(s) 3 3
Device Embedded In Tissue or Plaque 2 2
Uterine Perforation 1 1
Bowel Perforation 1 1
Foreign Body In Patient 1 1
Pain 1 1
Partial thickness (Second Degree) Burn 1 1

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