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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 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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