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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
Premarket Reviews
Manufacturer
Decision
PERCUVISION LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2017
1
1
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
Display or Visual Feedback Problem
4
4
No Display/Image
4
4
Material Deformation
4
4
Defective Component
4
4
Material Separation
4
4
Thermal Decomposition of Device
4
4
Disconnection
3
3
Poor Visibility
3
3
Optical Problem
3
3
Image Display Error/Artifact
3
3
Degraded
3
3
Scratched Material
2
2
Device Fell
2
2
Material Split, Cut or Torn
2
2
Separation Problem
2
2
Adverse Event Without Identified Device or Use Problem
1
1
Positioning Problem
1
1
Unraveled Material
1
1
Fogging
1
1
Material Fragmentation
1
1
Unintended Movement
1
1
Incomplete or Inadequate Connection
1
1
Pitted
1
1
Physical Resistance/Sticking
1
1
Fracture
1
1
Device Dislodged or Dislocated
1
1
Excessive Heating
1
1
Overheating of Device
1
1
Optical Obstruction
1
1
Naturally Worn
1
1
Corroded
1
1
Detachment Of Device Component
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
No Consequences Or Impact To Patient
1
1
Device Embedded In Tissue or Plaque
1
1
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