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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 288 288

Device Problems MDRs with this Device Problem Events in those MDRs
Break 435 435
Detachment of Device or Device Component 92 92
Crack 48 48
Loose or Intermittent Connection 27 27
Poor Quality Image 24 24
Component Missing 24 24
Mechanical Problem 17 17
Material Twisted/Bent 15 15
Material Integrity Problem 6 6
Failure to Align 5 5
Defective Component 4 4
Display or Visual Feedback Problem 4 4
Material Deformation 4 4
Thermal Decomposition of Device 4 4
No Display/Image 4 4
Disconnection 3 3
Image Display Error/Artifact 3 3
Optical Problem 3 3
Poor Visibility 3 3
Degraded 3 3
Separation Problem 2 2
Material Split, Cut or Torn 2 2
Device Fell 2 2
Material Separation 2 2
Scratched Material 2 2
Optical Obstruction 1 1
Overheating of Device 1 1
Naturally Worn 1 1
Pitted 1 1
Physical Resistance/Sticking 1 1
Incomplete or Inadequate Connection 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Fogging 1 1
Material Fragmentation 1 1
Unraveled Material 1 1
Corroded 1 1
Fracture 1 1
Excessive Heating 1 1
Device Dislodged or Dislocated 1 1
Positioning Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 666 666
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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