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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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 40 40
Material Split, Cut or Torn 36 36
Break 12 12
Material Separation 8 8
Insufficient Information 5 5
Material Fragmentation 5 5
Flaked 5 5
Material Integrity Problem 4 4
Device Fell 3 3
Detachment of Device or Device Component 3 3
Fracture 3 3
Material Frayed 2 2
Entrapment of Device 2 2
Peeled/Delaminated 2 2
Unraveled Material 2 2
Material Deformation 2 2
No Apparent Adverse Event 2 2
Device Markings/Labelling Problem 1 1
Contamination 1 1
Shipping Damage or Problem 1 1
Material Twisted/Bent 1 1
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 79
Foreign Body In Patient 14 14
No Consequences Or Impact To Patient 11 11
Insufficient Information 5 5
Device Embedded In Tissue or Plaque 4 4
No Known Impact Or Consequence To Patient 3 3
Injury 2 2
Sepsis 1 1
Gastrointestinal Hemorrhage 1 1
Perforation 1 1
Anemia 1 1
No Patient Involvement 1 1
Laceration(s) 1 1
Abscess 1 1
Tissue Damage 1 1

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