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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
Product CodeKNY
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2019 19 19
2020 36 36
2021 17 17
2022 19 19
2023 13 13
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 50 50
Fracture 14 14
Material Separation 14 14
Device Fell 8 8
Detachment of Device or Device Component 6 6
Material Fragmentation 5 5
Peeled/Delaminated 4 4
Material Twisted/Bent 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Difficult to Remove 1 1
Material Split, Cut or Torn 1 1
Sharp Edges 1 1
Material Frayed 1 1
Difficult to Insert 1 1
Problem with Sterilization 1 1
Stretched 1 1
Structural Problem 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
No Consequences Or Impact To Patient 20 20
No Patient Involvement 16 16
No Known Impact Or Consequence To Patient 11 11
Foreign Body In Patient 9 9
Device Embedded In Tissue or Plaque 4 4
Unspecified Kidney or Urinary Problem 3 3
Pulmonary Edema 3 3
Tissue Damage 2 2
Hematuria 2 2
Dysuria 1 1
Injury 1 1
Urinary Tract Infection 1 1
Swelling 1 1
Abrasion 1 1
Fever 1 1
Myocardial Infarction 1 1
Pain 1 1
Perforation 1 1

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