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TPLC
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show TPLC since
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Device
urethroscope
Regulation Description
Endoscope and accessories.
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
2025
560
560
2026
355
355
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
978
978
Detachment of Device or Device Component
294
294
Crack
128
128
Loose or Intermittent Connection
107
107
Poor Quality Image
48
48
Unstable
45
45
Component Missing
39
39
Material Fragmentation
24
24
Material Twisted/Bent
19
19
Mechanical Problem
19
19
Material Separation
17
17
Material Integrity Problem
16
16
Fracture
16
16
Degraded
15
15
Material Deformation
12
12
No Display/Image
11
11
Optical Problem
11
11
Material Split, Cut or Torn
9
9
Overheating of Device
9
9
Defective Component
7
7
Failure to Align
7
7
Melted
6
6
Unintended Movement
6
6
Thermal Decomposition of Device
6
6
Display or Visual Feedback Problem
6
6
Dent in Material
5
5
Scratched Material
5
5
Connection Problem
4
4
Separation Problem
4
4
Device Fell
3
3
Image Display Error/Artifact
3
3
Poor Visibility
3
3
Disconnection
3
3
Flare or Flash
2
2
Peeled/Delaminated
2
2
Optical Obstruction
2
2
Failure to Clean Adequately
2
2
Corroded
2
2
Defective Device
1
1
Device Dislodged or Dislocated
1
1
Failure to Power Up
1
1
Pitted
1
1
Positioning Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Excessive Heating
1
1
Contamination
1
1
Naturally Worn
1
1
Loss of or Failure to Bond
1
1
Physical Resistance/Sticking
1
1
Material Discolored
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1747
1747
Hemorrhage/Blood Loss/Bleeding
2
2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
2
2
Laceration(s)
1
1
Perforation
1
1
Ecchymosis
1
1
Rupture
1
1
Unspecified Gastrointestinal Problem
1
1
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