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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
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Product CodeBWA
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2022 3 3
2023 3 3
2024 10 11
2025 6 6
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Self-Activation or Keying 12 12
Energy Output Problem 11 12
Adverse Event Without Identified Device or Use Problem 4 5
Device Remains Activated 3 3
Unintended Power Up 2 2
Intermittent Energy Output 2 2
Insufficient Information 1 1
Material Integrity Problem 1 2
Failure to Cut 1 1
Inappropriate/Inadequate Shock/Stimulation 1 2
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Connection Problem 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 18
Insufficient Information 6 6
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
Electric Shock 1 2
Thrombosis/Thrombus 1 1
Unspecified Tissue Injury 1 2

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