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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device brush, biopsy, general & plastic surgery
Product CodeGEE
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 5 5
2022 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 3 3
Material Deformation 2 2
Break 2 2
Material Fragmentation 1 1
Leak/Splash 1 1
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Esophagus 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Hemorrhage/Bleeding 1 1
Perforation 1 1

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