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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device driver, surgical, pin
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFC
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 8 8
2022 7 7
2023 7 7
2024 13 14
2025 11 11
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 20 20
Material Twisted/Bent 12 12
Fracture 8 9
Mechanical Jam 5 5
Material Deformation 4 4
Corroded 3 3
Leak/Splash 2 2
Fail-Safe Did Not Operate 2 2
Fail-Safe Problem 2 2
Detachment of Device or Device Component 2 2
Excessive Heating 2 2
Premature Separation 2 2
Compatibility Problem 1 1
Degraded 1 1
Material Fragmentation 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Illegible Information 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 47
Insufficient Information 4 4
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 1 1

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