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TPLC
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show TPLC since
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Device
urethroscope
Product Code
FGC
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2021
2
2
2022
33
33
2023
346
346
2024
455
455
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
535
535
Detachment of Device or Device Component
111
111
Crack
68
68
Loose or Intermittent Connection
36
36
Poor Quality Image
27
27
Component Missing
27
27
Mechanical Problem
17
17
Material Twisted/Bent
16
16
Material Integrity Problem
8
8
No Display/Image
7
7
Failure to Align
7
7
Thermal Decomposition of Device
6
6
Display or Visual Feedback Problem
5
5
Material Deformation
5
5
Material Separation
5
5
Defective Component
4
4
Degraded
4
4
Disconnection
3
3
Image Display Error/Artifact
3
3
Optical Problem
3
3
Poor Visibility
3
3
Fracture
3
3
Material Split, Cut or Torn
2
2
Separation Problem
2
2
Unintended Movement
2
2
Device Fell
2
2
Optical Obstruction
2
2
Scratched Material
2
2
Material Fragmentation
2
2
Loss of or Failure to Bond
1
1
Corroded
1
1
Overheating of Device
1
1
Naturally Worn
1
1
Connection Problem
1
1
Excessive Heating
1
1
Device Dislodged or Dislocated
1
1
Pitted
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Unraveled Material
1
1
Fogging
1
1
Contamination
1
1
Positioning Problem
1
1
Peeled/Delaminated
1
1
Incomplete or Inadequate Connection
1
1
Physical Resistance/Sticking
1
1
Leak/Splash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
833
833
Hemorrhage/Bleeding
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Unspecified Gastrointestinal Problem
1
1
Perforation
1
1
Rupture
1
1
Ecchymosis
1
1
Laceration(s)
1
1
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