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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pliers, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeHTC
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 25 25
2021 18 18
2022 22 22
2023 8 8
2024 27 27
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 72 72
Mechanical Problem 7 7
Device-Device Incompatibility 6 6
Detachment of Device or Device Component 6 6
Fracture 6 6
Material Integrity Problem 5 5
Compatibility Problem 3 3
Crack 3 3
Material Twisted/Bent 3 3
Failure to Cut 3 3
Material Deformation 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Difficult to Open or Close 2 2
Corroded 2 2
Mechanical Jam 2 2
Entrapment of Device 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 84 84
No Consequences Or Impact To Patient 16 16
Insufficient Information 7 7
No Patient Involvement 5 5
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 1 1
Burn(s) 1 1
Hemorrhage/Bleeding 1 1

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