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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lamp, operating-room
Regulation Description Surgical lamp.
Product CodeFQP
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 7 7
2024 1 1
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Compatibility Problem 15 15
Material Integrity Problem 10 10
Mechanical Problem 9 9
Detachment of Device or Device Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
Insufficient Information 3 3
Hematoma 2 2
Bruise/Contusion 2 2
Head Injury 1 1

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