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TPLC
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show TPLC since
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Device
resectoscope, working element
Product Code
FDC
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
14
14
2020
10
10
2021
5
5
2022
5
5
2023
10
10
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
19
19
Temperature Problem
5
5
Unintended Electrical Shock
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Overheating of Device
3
3
Material Separation
3
3
Fire
2
2
Detachment of Device or Device Component
2
2
Mechanical Problem
2
2
Power Problem
1
1
Thermal Decomposition of Device
1
1
Intermittent Energy Output
1
1
Excessive Heating
1
1
Appropriate Term/Code Not Available
1
1
Device Handling Problem
1
1
Electrical Shorting
1
1
Flare or Flash
1
1
Material Integrity Problem
1
1
Fracture
1
1
Difficult to Insert
1
1
Loose or Intermittent Connection
1
1
Smoking
1
1
Arcing of Electrodes
1
1
Defective Device
1
1
Sparking
1
1
Ambient Noise Problem
1
1
Connection Problem
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
7
7
Insufficient Information
6
6
Full thickness (Third Degree) Burn
3
3
Foreign Body In Patient
3
3
No Known Impact Or Consequence To Patient
2
2
Burn, Thermal
2
2
Electric Shock
2
2
No Patient Involvement
2
2
Hemorrhage/Bleeding
2
2
Laceration(s)
1
1
Perforation
1
1
Tissue Damage
1
1
Burn(s)
1
1
Death
1
1
Unspecified Tissue Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
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