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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device light, surgical, floor standing
Regulation Description Surgical lamp.
Product CodeFSS
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2016 2 2
2017 2 2
2019 13 13
2020 9 9
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 10 10
Break 8 8
Crack 8 8
Improper or Incorrect Procedure or Method 6 6
Mechanical Problem 3 3
Melted 2 2
Failure to Power Up 2 2
Device Markings/Labelling Problem 2 2
Device Dislodged or Dislocated 2 2
Corroded 2 2
Device Tipped Over 2 2
Defective Device 1 1
Installation-Related Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Unexpected Shutdown 1 1
Smoking 1 1
Electrical /Electronic Property Problem 1 1
Thermal Decomposition of Device 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 9 9
No Patient Involvement 7 7
No Clinical Signs, Symptoms or Conditions 5 5
Patient Problem/Medical Problem 1 1

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