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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 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Break 76 76
Crack 18 18
Poor Quality Image 9 9
Detachment of Device or Device Component 8 8
Material Twisted/Bent 5 5
Component Missing 4 4
Material Deformation 2 2
No Display/Image 2 2
Mechanical Problem 2 2
Optical Problem 1 1
Scratched Material 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Display or Visual Feedback Problem 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 110 110
Perforation 1 1

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