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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urethrotome
Product CodeEZO
Regulation Number 876.4770
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 2 2
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5 5
Fracture 4 4
Mechanical Problem 2 2
Material Separation 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 4 4
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 3 3

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