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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light, catheter, fiberoptic, glass, ureteral
Regulation Description Fiberoptic light ureteral catheter.
Product CodeFCS
Regulation Number 876.4020
Device Class 2

MDR Year MDR Reports MDR Events
2021 6 6
2022 19 19
2023 4 4
2024 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Packaging Problem 10 10
Device Contamination with Chemical or Other Material 6 6
Contamination /Decontamination Problem 5 5
Break 4 4
Output Problem 4 4
Contamination 4 4
Device Unsafe to Use in Environment 4 4
Patient-Device Incompatibility 3 3
Insufficient Information 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Material Fragmentation 2 2
Fracture 2 2
Device Contaminated During Manufacture or Shipping 1 1
Activation Problem 1 1
Device Markings/Labelling Problem 1 1
Difficult to Advance 1 1
Expiration Date Error 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Use of Device Problem 1 1
Delivered as Unsterile Product 1 1
Optical Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Insufficient Information 22 22
Renal Failure 3 3
Uterine Perforation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Perforation 1 1

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