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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pliers, surgical
Product CodeHTC
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 23 23
2020 25 25
2021 18 18
2022 22 22
2023 8 8
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 71 71
Device-Device Incompatibility 10 10
Detachment of Device or Device Component 7 7
Mechanical Problem 5 5
Crack 4 4
Material Integrity Problem 4 4
Failure to Cut 3 3
Fracture 3 3
Material Deformation 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Device Difficult to Maintain 2 2
Entrapment of Device 2 2
Corroded 2 2
Material Twisted/Bent 2 2
Compatibility Problem 2 2
Difficult to Open or Close 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Loose or Intermittent Connection 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61 61
No Consequences Or Impact To Patient 27 27
No Patient Involvement 14 14
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 2 2
Foreign Body In Patient 2 2
Burn(s) 1 1
Hemorrhage/Bleeding 1 1

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