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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
2014 55 55
2015 41 41
2016 57 57
2018 17 17
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 162 162
Electrical /Electronic Property Problem 79 79
Intermittent Continuity 44 44
Break 39 39
Device Stops Intermittently 16 16
Device Operates Differently Than Expected 13 13
Loss of Power 13 13
Insufficient Information 13 13
Power Problem 11 11
Crack 11 11
Component Missing 11 11
Failure to Power Up 9 9
Noise, Audible 7 7
Detachment of Device or Device Component 7 7
Connection Problem 6 6
Device Inoperable 5 5
Smoking 5 5
Intermittent Loss of Power 5 5
Electrical Shorting 4 4
Environmental Compatibility Problem 4 4
Device Remains Activated 4 4
Loose or Intermittent Connection 3 3
Mechanical Problem 3 3
Defective Component 3 3
Overheating of Device 3 3
Failure to Deliver 3 3
No Apparent Adverse Event 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 2 2
Expiration Date Error 2 2
Failure to Cut 2 2
Defective Device 2 2
Environmental Particulates 2 2
Energy Output Problem 2 2
Self-Activation or Keying 2 2
Disconnection 2 2
Device Alarm System 1 1
Material Frayed 1 1
High impedance 1 1
Unintended Power Up 1 1
Charred 1 1
Device Maintenance Issue 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Volume Accuracy Problem 1 1
Application Program Problem 1 1
Calibration Problem 1 1
Power Conditioning Problem 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Material Split, Cut or Torn 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 122 122
No Known Impact Or Consequence To Patient 104 104
No Patient Involvement 66 66
Insufficient Information 17 17
No Information 6 6
Hemorrhage/Bleeding 4 4
Surgical procedure 2 2
Blood Loss 1 1
Unspecified Infection 1 1
No Code Available 1 1
Burn(s) 1 1

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