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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stylet, ureteral
Product CodeEYA
Regulation Number 876.5130
Device Class 1

MDR Year MDR Reports MDR Events
2019 11 11
2020 8 8
2021 33 33
2022 21 21
2023 26 26
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 37 37
Material Split, Cut or Torn 28 28
Break 12 12
Material Separation 8 8
Material Fragmentation 5 5
Flaked 5 5
Material Integrity Problem 4 4
Device Fell 3 3
Fracture 3 3
Insufficient Information 3 3
Detachment of Device or Device Component 3 3
Entrapment of Device 2 2
Peeled/Delaminated 2 2
No Apparent Adverse Event 2 2
Unraveled Material 2 2
Material Frayed 2 2
Device Dislodged or Dislocated 1 1
Material Twisted/Bent 1 1
Contamination 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 70
Foreign Body In Patient 12 12
No Consequences Or Impact To Patient 11 11
Device Embedded In Tissue or Plaque 4 4
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 3 3
Injury 2 2
No Patient Involvement 1 1
Tissue Damage 1 1

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