BEUDAMED
    FDA Adverse Event Summary report: N

    QUANTUM SURGICAL LIGHTING SYSTEM

    MDR report key: 22633 · Received June 21, 1995

    Report

    Report Number
    MW1006301
    Date Received
    June 21, 1995
    Date of Event
    April 20, 1995
    Report Date
    May 5, 1995
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    FSY
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGICAL LIGHT FOCUSING VANES ARE MADE OF PLASTIC AND ARE BREAKING OFF OF OPERATING SHAFTS. BROKEN PARTS CANNOT REACH PT BECAUSE OF THE PLASTIC LENS. PARTS ARE FAILING PROBABLY DUE TO THE HIGH TEMPERATURES ENCOUNTERED INSIDE THE LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM SURGICAL LIGHTING SYSTEM SURGICAL LIGHTING SYSTEM FSY AMERICAN STERILIZER CO. QUANTUM

    Patients

    Seq Age Sex Outcome Treatment
    1 *