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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrosurgical device
Product CodeDWG
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2023 5 5
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 3 3
Use of Device Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 4 4
Burning Sensation 2 2
Discomfort 2 2
Electric Shock 1 1
Increased Sensitivity 1 1
Scar Tissue 1 1

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