BEUDAMED
    FDA Adverse Event Summary report: N

    LUXTEX MLX

    MDR report key: 2598266 · Received May 29, 2012

    Report

    Report Number
    2598266
    Date Received
    May 29, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 29, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GCT
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE A SURGICAL ILLUMINATOR WAS CONNECTED TO A LUXTEX LIGHT SOURCE. THE SURGICAL ILLUMINATOR WAS A LIGHT MAT, MFG, LUMITEXMD INC. REF# UA2550 LOT# I01802. THE CIRCULATING NURSE NOTICED AN ELECTRICAL BURNING SMELL THAT CONTINUED TO GET WORSE. SHE DISCOVERED THE CORD FROM THE SURGICAL ILLUMINATOR WAS SMOKING. SHE WENT TO REMOVE THE CORD AND AS SHE GRABBED THE CORD TO REMOVE IT FROM THE LIGHT SOURCE, SHE BURNED HER FINGERS. THE METAL CONNECTION OF THE SURGICAL ILLUMINATOR WAS VERY HOT.======================MANUFACTURER RESPONSE FOR LIGHT SOURCES, XENON, LUXTEX MLX (PER SITE REPORTER).======================THEY TOLD US WE ARE NOT USING THEIR ILLIMINATOR SO IT IS OUR PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXTEX MLX LIGHT SOURCES, XENON GCT INTEGRA LIFESCIENCES CORP. MLX *
    2 LIGHT MAT ULTRA-THIN FLEXIBLE LIGHT CABLE FDG LUMITEX MEDICAL DEVICES, INC. * I01802

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES