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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, flexible suction coagulator
Product CodeFEH
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
OPTIM LLC
  SUBSTANTIALLY EQUIVALENT 1
OPTIM, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 1 1
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Detachment Of Device Component 1 1
Material Separation 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 1 1
No Consequences Or Impact To Patient 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1

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