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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, electrosurgical
Product CodeJOS
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2019 17 17
2020 12 12
2021 5 5
2022 8 8
2023 9 9
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 20 20
Material Fragmentation 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Mechanical Problem 5 5
Fracture 4 4
Material Separation 3 3
Deformation Due to Compressive Stress 3 3
Detachment of Device or Device Component 3 3
Insufficient Information 3 3
Excessive Heating 3 3
Sparking 2 2
Temperature Problem 1 1
Device Dislodged or Dislocated 1 1
Flare or Flash 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Partial Blockage 1 1
Entrapment of Device 1 1
Melted 1 1
Material Rupture 1 1
Grounding Malfunction 1 1
High impedance 1 1
Separation Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Consequences Or Impact To Patient 11 11
Insufficient Information 7 7
Device Embedded In Tissue or Plaque 3 3
Burn, Thermal 3 3
Burn(s) 3 3
Foreign Body In Patient 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 1 1
No Known Impact Or Consequence To Patient 1 1
Pain 1 1
Uterine Perforation 1 1
Bowel Perforation 1 1
No Information 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Dec-11-2019
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