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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2019
2020
2021
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2023
2024
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Device
unit, cautery, thermal, ac-powered
Product Code
HQO
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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