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TPLC
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show TPLC since
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2024
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Device
resectoscope, working element
Product Code
FDC
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
29
29
2015
12
12
2016
1
1
2017
9
9
2018
4
4
2019
14
14
2020
10
10
2021
5
5
2022
5
5
2023
10
10
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
38
38
Sparking
10
10
Material Fragmentation
9
9
Temperature Problem
5
5
Electrical /Electronic Property Problem
4
4
Fracture
4
4
Inappropriate/Inadequate Shock/Stimulation
3
3
Overheating of Device
3
3
Material Separation
3
3
Unintended Power Up
3
3
Detachment Of Device Component
3
3
Grounding Malfunction
3
3
Fire
3
3
Mechanical Problem
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Unintended Electrical Shock
3
3
Device Handling Problem
2
2
Detachment of Device or Device Component
2
2
Bent
2
2
Thermal Decomposition of Device
2
2
Inadequate Service
2
2
Device Stops Intermittently
2
2
Arcing of Electrodes
2
2
Component Missing
1
1
Device Issue
1
1
Defective Device
1
1
Use of Device Problem
1
1
Ambient Noise Problem
1
1
Connection Problem
1
1
Smoking
1
1
Failure To Service
1
1
Therapy Delivered to Incorrect Body Area
1
1
Component Falling
1
1
Degraded
1
1
Material Discolored
1
1
Entrapment of Device
1
1
Melted
1
1
Difficult to Insert
1
1
Loose or Intermittent Connection
1
1
Device Disinfection Or Sterilization Issue
1
1
Device Operates Differently Than Expected
1
1
Device Damaged by Another Device
1
1
Electrical Shorting
1
1
Flare or Flash
1
1
Maintenance Does Not Comply To Manufacturers Recommendations
1
1
Material Integrity Problem
1
1
Excessive Heating
1
1
Output Problem
1
1
Power Problem
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
35
35
No Clinical Signs, Symptoms or Conditions
14
14
No Known Impact Or Consequence To Patient
13
13
Foreign Body In Patient
12
12
Insufficient Information
6
6
Electric Shock
6
6
Burn, Thermal
3
3
Full thickness (Third Degree) Burn
3
3
Lead(s), Burn(s) From
3
3
Flashers
3
3
Hemorrhage/Bleeding
3
3
No Patient Involvement
3
3
No Code Available
2
2
Laceration(s)
2
2
Shock
2
2
Burn(s)
2
2
Death
1
1
Electrocution
1
1
Hearing Loss
1
1
Tissue Damage
1
1
Twitching
1
1
Perforation
1
1
Device Embedded In Tissue or Plaque
1
1
Fibrosis
1
1
Blood Loss
1
1
Unspecified Tissue Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
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