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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
electrode, electrosurgical
Regulation Description
Electrosurgical cutting and coagulation device and accessories.
Product Code
JOS
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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
17
17
Material Fragmentation
7
7
Mechanical Problem
5
5
Fracture
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Insufficient Information
3
3
Detachment of Device or Device Component
3
3
Partial Blockage
1
1
High impedance
1
1
Material Twisted/Bent
1
1
Separation Problem
1
1
Excessive Heating
1
1
Material Rupture
1
1
Material Separation
1
1
Temperature Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Melted
1
1
Entrapment of Device
1
1
Device Dislodged or Dislocated
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
19
19
Insufficient Information
7
7
No Consequences Or Impact To Patient
4
4
Burn(s)
3
3
Device Embedded In Tissue or Plaque
2
2
Foreign Body In Patient
1
1
Partial thickness (Second Degree) Burn
1
1
Bowel Perforation
1
1
Pain
1
1
Uterine Perforation
1
1
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