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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light, surgical, floor standing
Regulation Description Surgical lamp.
Product CodeFSS
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 3 3
2023 15 18
2024 11 13
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 27 32
Crack 7 8
Peeled/Delaminated 7 9
Fracture 3 3
Material Split, Cut or Torn 2 3
Break 2 2
Melted 2 2
Unintended Electrical Shock 1 1
Device Fell 1 1
Failure to Power Up 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 40
Superficial (First Degree) Burn 1 1
Concussion 1 1

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