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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, electrosurgical and coagulation, with accessories
Product CodeBWA
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2017 5 5
2018 2 2
2019 1 1
2022 3 3
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Self-Activation or Keying 6 6
Fire 3 3
Device Remains Activated 3 3
Energy Output Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Intermittent Energy Output 1 1
Component Missing 1 1
Overheating of Device 1 1
Unintended Power Up 1 1
Energy Output To Patient Tissue Incorrect 1 1
Failure to Deliver Energy 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 2 2
Partial thickness (Second Degree) Burn 1 1
Thrombosis/Thrombus 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Abscess 1 1
Fever 1 1
Fistula 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Liver Laceration(s) 1 1
No Patient Involvement 1 1
Superficial (First Degree) Burn 1 1

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