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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device snare, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeGAE
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 12 12
2024 13 13
2025 9 9
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Detachment of Device or Device Component 3 3
Material Twisted/Bent 2 2
Entrapment of Device 1 1
Defective Device 1 1
Mechanics Altered 1 1
Material Deformation 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Unexpected Therapeutic Results 1 1
Firing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Foreign Body In Patient 8 8
Pericardial Effusion 3 3
Insufficient Information 3 3
Low Blood Pressure/ Hypotension 2 2
Perforation 1 1
Laceration(s) 1 1

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