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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
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2019
2020
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2024
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Device
light, surgical, floor standing
Product Code
FSS
Regulation Number
878.4580
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
13
13
2020
9
9
2021
5
5
2022
3
3
2023
15
15
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
32
32
Crack
13
13
Break
9
9
Peeled/Delaminated
6
6
Improper or Incorrect Procedure or Method
6
6
Mechanical Problem
3
3
Fracture
3
3
Material Split, Cut or Torn
2
2
Device Markings/Labelling Problem
2
2
Failure to Power Up
2
2
Device Dislodged or Dislocated
2
2
Melted
2
2
Unexpected Shutdown
1
1
Device Tipped Over
1
1
Unintended Movement
1
1
Defective Device
1
1
Installation-Related Problem
1
1
Protective Measures Problem
1
1
Electrical /Electronic Property Problem
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
31
31
No Consequences Or Impact To Patient
8
8
No Patient Involvement
7
7
No Known Impact Or Consequence To Patient
7
7
Concussion
1
1
Patient Problem/Medical Problem
1
1
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