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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, electrosurgical
Product CodeHAM
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2018 6 6
2019 11 11
2020 3 3
2021 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 7 7
Packaging Problem 3 3
Defective Component 2 2
Tear, Rip or Hole in Device Packaging 2 2
Break 1 1
Fire 1 1
Activation Problem 1 1
Material Erosion 1 1
Energy Output Problem 1 1
Failure to Cut 1 1
Detachment of Device or Device Component 1 1
Electrical Shorting 1 1
Protective Measures Problem 1 1
Melted 1 1
Self-Activation or Keying 1 1
Arcing 1 1
Detachment Of Device Component 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 12 12
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 3 3
Superficial (First Degree) Burn 2 2
Pneumothorax 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
No Information 1 1
Burn(s) 1 1

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