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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
2018 13 13
2019 11 11
2020 8 8
2021 33 33
2022 21 21
2023 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 35 35
Material Split, Cut or Torn 14 14
Break 12 12
Unraveled Material 9 9
Material Separation 8 8
Flaked 6 6
Material Fragmentation 6 6
Material Integrity Problem 4 4
Material Frayed 3 3
Fracture 3 3
Device Fell 3 3
Insufficient Information 2 2
Detachment Of Device Component 2 2
Entrapment of Device 2 2
Peeled/Delaminated 2 2
Mechanical Problem 1 1
Contamination 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
Foreign Body In Patient 13 13
No Consequences Or Impact To Patient 11 11
No Known Impact Or Consequence To Patient 9 9
Device Embedded In Tissue or Plaque 4 4
Insufficient Information 3 3
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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