BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 2652680 · Received June 25, 2012

    Report

    Report Number
    1222895-2012-00015
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Date of Event
    May 21, 2012
    Report Date
    June 25, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FST
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH# (B)(4) REPORTS THAT DURING A SURGICAL PROCEDURE A SURGICAL ILLUMINATOR WAS CONNECTED TO A LUXTEC LIGHT SOURCE. THE SURGICAL ILLUMINATOR WAS A LIGHT MAT, MANUFACTURER: LUMITEX MEDICAL DEVICES INC, REF# (B)(4), 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MLX 300W XENON LIGHTSOURCE NA FST INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 LIGHT MAT SURGICAL ILLUMINATOR: REF# (B)(4)| LOT # I01802| MANUFACTURER: LUMITEX MEDICAL DEVICES INC.