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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urethroscope
Product CodeFGC
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2022 33 33
2023 346 346
2024 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Break 343 343
Detachment of Device or Device Component 65 65
Crack 36 36
Poor Quality Image 22 22
Loose or Intermittent Connection 19 19
Mechanical Problem 17 17
Component Missing 16 16
Material Twisted/Bent 9 9
Material Deformation 4 4
No Display/Image 4 4
Image Display Error/Artifact 3 3
Defective Component 3 3
Material Split, Cut or Torn 2 2
Device Fell 2 2
Separation Problem 2 2
Material Integrity Problem 2 2
Failure to Align 2 2
Optical Problem 2 2
Disconnection 2 2
Display or Visual Feedback Problem 2 2
Thermal Decomposition of Device 2 2
Corroded 1 1
Degraded 1 1
Fogging 1 1
Fracture 1 1
Pitted 1 1
Material Separation 1 1
Unraveled Material 1 1
Scratched Material 1 1
Unintended Movement 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Poor Visibility 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 499 499
Hemorrhage/Bleeding 2 2
Laceration(s) 1 1
Perforation 1 1
Rupture 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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