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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
2017 7 7
2018 13 13
2019 11 11
2020 8 8
2021 33 33
2022 21 21
2023 26 26
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 37 37
Material Split, Cut or Torn 26 26
Break 15 15
Unraveled Material 14 14
Material Separation 8 8
Flaked 6 6
Material Fragmentation 6 6
Material Integrity Problem 4 4
Detachment of Device or Device Component 3 3
Material Frayed 3 3
Peeled/Delaminated 3 3
Fracture 3 3
Detachment Of Device Component 3 3
Device Fell 3 3
Insufficient Information 3 3
No Apparent Adverse Event 2 2
Entrapment of Device 2 2
Mechanical Problem 1 1
Contamination 1 1
Device Markings/Labelling Problem 1 1
Uncoiled 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Handling Problem 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 68
No Consequences Or Impact To Patient 18 18
Foreign Body In Patient 16 16
No Known Impact Or Consequence To Patient 9 9
Device Embedded In Tissue or Plaque 4 4
Insufficient Information 4 4
Injury 2 2
No Patient Involvement 1 1
Tissue Damage 1 1
Uterine Perforation 1 1
No Information 1 1
No Code Available 1 1

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