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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, carrier
Regulation Description Surgical lamp.
Product CodeFSZ
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2019 2 2
2020 3 3
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Pressure Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Melted 1 1
Overheating of Device 1 1
Material Separation 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Burn(s) 2 2
Superficial (First Degree) Burn 2 2
Neurological Deficit/Dysfunction 1 1
No Consequences Or Impact To Patient 1 1
Insufficient Information 1 1

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