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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stripper, vein, reusable
Regulation Description Manual surgical instrument for general use.
Product CodeGAI
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 5 5
2018 4 4
2019 1 1
2020 9 9
2021 1 1
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8 8
Detachment of Device or Device Component 7 7
Fracture 5 5
Material Fragmentation 4 4
Entrapment of Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Suction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 6 6
Foreign Body In Patient 5 5
Partial thickness (Second Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1

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