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TPLC
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show TPLC since
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2024
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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
288
288
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
435
435
Detachment of Device or Device Component
92
92
Crack
48
48
Loose or Intermittent Connection
27
27
Poor Quality Image
24
24
Component Missing
24
24
Mechanical Problem
17
17
Material Twisted/Bent
15
15
Material Integrity Problem
6
6
Failure to Align
5
5
Defective Component
4
4
Display or Visual Feedback Problem
4
4
Material Deformation
4
4
Thermal Decomposition of Device
4
4
No Display/Image
4
4
Disconnection
3
3
Image Display Error/Artifact
3
3
Optical Problem
3
3
Poor Visibility
3
3
Degraded
3
3
Separation Problem
2
2
Material Split, Cut or Torn
2
2
Device Fell
2
2
Material Separation
2
2
Scratched Material
2
2
Optical Obstruction
1
1
Overheating of Device
1
1
Naturally Worn
1
1
Pitted
1
1
Physical Resistance/Sticking
1
1
Incomplete or Inadequate Connection
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Fogging
1
1
Material Fragmentation
1
1
Unraveled Material
1
1
Corroded
1
1
Fracture
1
1
Excessive Heating
1
1
Device Dislodged or Dislocated
1
1
Positioning Problem
1
1
Unintended Movement
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
666
666
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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