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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, cautery, thermal, ac-powered
Product CodeHQO
Regulation Number 886.4115
Device Class 2

MDR Year MDR Reports MDR Events
2019 73 73
2020 44 44
2021 56 56
2022 53 53
2023 48 48
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver Energy 131 131
Electrical /Electronic Property Problem 74 74
Intermittent Continuity 30 30
Break 25 25
Crack 10 10
Component Missing 7 7
Detachment of Device or Device Component 6 6
Intermittent Loss of Power 5 5
Noise, Audible 4 4
Power Problem 4 4
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Mechanical Problem 2 2
Failure to Power Up 2 2
Electrical Shorting 2 2
Smoking 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Defective Component 2 2
Expiration Date Error 2 2
Energy Output Problem 1 1
Self-Activation or Keying 1 1
Unintended Power Up 1 1
Material Frayed 1 1
Connection Problem 1 1
Failure to Deliver 1 1
Material Split, Cut or Torn 1 1
Unintended Movement 1 1
Defective Device 1 1
Overheating of Device 1 1
Positioning Problem 1 1
Volume Accuracy Problem 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 146 146
No Consequences Or Impact To Patient 75 75
No Patient Involvement 48 48
Insufficient Information 17 17
No Known Impact Or Consequence To Patient 12 12
Hemorrhage/Bleeding 4 4

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