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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dissector, surgical, general & plastic surgery
Product CodeGDI
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 4 4
2023 6 6
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Adverse Event Without Identified Device or Use Problem 6 6
Mechanical Jam 3 3
Fracture 2 2
Device-Device Incompatibility 1 1
Material Integrity Problem 1 1
Material Fragmentation 1 1
Device Handling Problem 1 1
Mechanical Problem 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Cardiac Perforation 5 5
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 1 1
No Patient Involvement 1 1
Hemorrhage/Bleeding 1 1

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