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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urethroscope
Regulation Description Endoscope and accessories.
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 455 455
2025 245 245

Device Problems MDRs with this Device Problem Events in those MDRs
Break 715 715
Detachment of Device or Device Component 128 128
Crack 90 90
Loose or Intermittent Connection 38 38
Poor Quality Image 36 36
Component Missing 29 29
Material Twisted/Bent 19 19
Mechanical Problem 18 18
Material Integrity Problem 10 10
No Display/Image 9 9
Fracture 8 8
Material Deformation 7 7
Failure to Align 7 7
Material Separation 6 6
Optical Problem 6 6
Thermal Decomposition of Device 6 6
Display or Visual Feedback Problem 5 5
Degraded 5 5
Overheating of Device 4 4
Defective Component 4 4
Disconnection 3 3
Material Split, Cut or Torn 3 3
Image Display Error/Artifact 3 3
Connection Problem 3 3
Poor Visibility 3 3
Dent in Material 3 3
Optical Obstruction 2 2
Melted 2 2
Material Fragmentation 2 2
Scratched Material 2 2
Device Fell 2 2
Unintended Movement 2 2
Separation Problem 2 2
Flare or Flash 1 1
Failure to Power Up 1 1
Unraveled Material 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pitted 1 1
Fogging 1 1
Contamination 1 1
Positioning Problem 1 1
Device Dislodged or Dislocated 1 1
Excessive Heating 1 1
Peeled/Delaminated 1 1
Naturally Worn 1 1
Incomplete or Inadequate Connection 1 1
Physical Resistance/Sticking 1 1
Leak/Splash 1 1
Corroded 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1078 1078
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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