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TPLC
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show TPLC since
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Device
electrode, electrosurgical
Product Code
JOS
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
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
21
21
Material Fragmentation
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Mechanical Problem
5
5
Fracture
4
4
Deformation Due to Compressive Stress
3
3
Detachment of Device or Device Component
3
3
Material Separation
3
3
Excessive Heating
3
3
Insufficient Information
3
3
Sparking
2
2
Material Twisted/Bent
1
1
Flare or Flash
1
1
Temperature Problem
1
1
Entrapment of Device
1
1
High impedance
1
1
Partial Blockage
1
1
Device Dislodged or Dislocated
1
1
Melted
1
1
Grounding Malfunction
1
1
Separation Problem
1
1
Material Split, Cut or Torn
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Material Rupture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
18
18
No Consequences Or Impact To Patient
11
11
Insufficient Information
7
7
Burn, Thermal
3
3
Burn(s)
3
3
Device Embedded In Tissue or Plaque
3
3
Foreign Body In Patient
2
2
Partial thickness (Second Degree) Burn
2
2
Uterine Perforation
1
1
Bowel Perforation
1
1
No Information
1
1
No Known Impact Or Consequence To Patient
1
1
Pain
1
1
Bacterial Infection
1
1
Full thickness (Third Degree) Burn
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Dec-11-2019
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