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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 455 455

Device Problems MDRs with this Device Problem Events in those MDRs
Break 535 535
Detachment of Device or Device Component 111 111
Crack 68 68
Loose or Intermittent Connection 36 36
Poor Quality Image 27 27
Component Missing 27 27
Mechanical Problem 17 17
Material Twisted/Bent 16 16
Material Integrity Problem 8 8
No Display/Image 7 7
Failure to Align 7 7
Thermal Decomposition of Device 6 6
Display or Visual Feedback Problem 5 5
Material Deformation 5 5
Material Separation 5 5
Defective Component 4 4
Degraded 4 4
Disconnection 3 3
Image Display Error/Artifact 3 3
Optical Problem 3 3
Poor Visibility 3 3
Fracture 3 3
Material Split, Cut or Torn 2 2
Separation Problem 2 2
Unintended Movement 2 2
Device Fell 2 2
Optical Obstruction 2 2
Scratched Material 2 2
Material Fragmentation 2 2
Loss of or Failure to Bond 1 1
Corroded 1 1
Overheating of Device 1 1
Naturally Worn 1 1
Connection Problem 1 1
Excessive Heating 1 1
Device Dislodged or Dislocated 1 1
Pitted 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unraveled Material 1 1
Fogging 1 1
Contamination 1 1
Positioning Problem 1 1
Peeled/Delaminated 1 1
Incomplete or Inadequate Connection 1 1
Physical Resistance/Sticking 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 833 833
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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