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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
Regulation Description Manual surgical instrument for general use.
Product CodeGDI
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 4 4
2023 6 6
2024 20 20
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Adverse Event Without Identified Device or Use Problem 7 7
Mechanical Jam 3 3
Mechanical Problem 1 1
Device-Device Incompatibility 1 1
Appropriate Term/Code Not Available 1 1
Fracture 1 1
Material Split, Cut or Torn 1 1
Material Fragmentation 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
Cardiac Perforation 6 6
Insufficient Information 4 4
Foreign Body In Patient 1 1
No Patient Involvement 1 1
Hemorrhage/Bleeding 1 1
No Known Impact Or Consequence To Patient 1 1
No Consequences Or Impact To Patient 1 1

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