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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
195
195
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
383
383
Detachment of Device or Device Component
75
75
Crack
43
43
Poor Quality Image
23
23
Loose or Intermittent Connection
20
20
Component Missing
18
18
Mechanical Problem
17
17
Material Twisted/Bent
10
10
Material Integrity Problem
5
5
Material Deformation
4
4
Thermal Decomposition of Device
4
4
No Display/Image
4
4
Display or Visual Feedback Problem
4
4
Degraded
3
3
Material Separation
3
3
Failure to Align
3
3
Image Display Error/Artifact
3
3
Defective Component
3
3
Optical Problem
3
3
Scratched Material
2
2
Material Split, Cut or Torn
2
2
Device Fell
2
2
Disconnection
2
2
Separation Problem
2
2
Poor Visibility
1
1
Unraveled Material
1
1
Pitted
1
1
Fogging
1
1
Fracture
1
1
Material Fragmentation
1
1
Detachment Of Device Component
1
1
Corroded
1
1
Incomplete or Inadequate Connection
1
1
Physical Resistance/Sticking
1
1
Unintended Movement
1
1
Naturally Worn
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Dislodged or Dislocated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
573
573
Hemorrhage/Bleeding
2
2
Laceration(s)
1
1
Perforation
1
1
No Consequences Or Impact To Patient
1
1
Rupture
1
1
Device Embedded In Tissue or Plaque
1
1
Unspecified Gastrointestinal Problem
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Ecchymosis
1
1
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