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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
2020 4 4
2021 1 1
2022 1 1
2023 12 12
2024 13 13
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 17
Detachment of Device or Device Component 3 3
Entrapment of Device 1 1
Crack 1 1
Use of Device Problem 1 1
Mechanics Altered 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Unexpected Therapeutic Results 1 1
Difficult to Open or Close 1 1
Firing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Foreign Body In Patient 8 8
Insufficient Information 3 3
Pericardial Effusion 2 2
No Patient Involvement 2 2
Low Blood Pressure/ Hypotension 2 2
Perforation 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1

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