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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 155 155

Device Problems MDRs with this Device Problem Events in those MDRs
Break 360 360
Detachment of Device or Device Component 67 67
Crack 39 39
Poor Quality Image 23 23
Loose or Intermittent Connection 20 20
Mechanical Problem 17 17
Component Missing 17 17
Material Twisted/Bent 9 9
Material Deformation 4 4
Thermal Decomposition of Device 4 4
No Display/Image 4 4
Display or Visual Feedback Problem 4 4
Degraded 3 3
Image Display Error/Artifact 3 3
Defective Component 3 3
Material Integrity Problem 3 3
Failure to Align 3 3
Optical Problem 3 3
Scratched Material 2 2
Material Split, Cut or Torn 2 2
Device Fell 2 2
Separation Problem 2 2
Disconnection 2 2
Corroded 1 1
Fogging 1 1
Fracture 1 1
Pitted 1 1
Material Separation 1 1
Unraveled Material 1 1
Poor Visibility 1 1
Physical Resistance/Sticking 1 1
Unintended Movement 1 1
Device Dislodged or Dislocated 1 1
Naturally Worn 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 533 533
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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