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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, catheter, g-u
Regulation Description Urological catheter and accessories.
Product CodeKNY
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2021 17 17
2022 19 24
2023 13 13
2024 5 5
2025 3 3
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 28
Material Separation 14 14
Detachment of Device or Device Component 7 7
Material Twisted/Bent 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Fell 2 2
Material Fragmentation 2 2
Material Frayed 1 1
Difficult to Insert 1 1
Peeled/Delaminated 1 1
Difficult to Remove 1 1
Structural Problem 1 1
Defective Device 1 1
Fracture 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Material Split, Cut or Torn 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 48
Foreign Body In Patient 6 6
Unspecified Kidney or Urinary Problem 3 3
Pulmonary Edema 3 3
No Consequences Or Impact To Patient 2 2
Unspecified Infection 1 1
Hematuria 1 1
Fever 1 1
Pain 1 1
Myocardial Infarction 1 1
Urinary Tract Infection 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Nov-12-2024
2 Olympus Corporation of the Americas II Aug-14-2023
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