BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 2960955 · Received February 11, 2013

    Report

    Report Number
    1222895-2013-00004
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    PMA / PMN Number
    K081477
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INITIALLY REPORTS THEY USED A NON-LUXTEC HEADLIGHT IN THE MLX LIGHT SOURCE AND EXPERIENCED MULTIPLE INCIDENCES (3X) OF SEVERE BURNS (2ND DEGREE BURNS) TO SURGERY STAFF DUE TO EXTREME TEMPERATURE OF LIGHT CORD CONNECTOR ONCE REMOVED AFTER USE. THESE THREE INCIDENCES OCCURRED OVER A PERIOD OF TIME BETWEEN (B)(6) 2013 AND (B)(6) 2013. THE HEADLIGHT THE CUSTOMER WAS USING WITH THE MLX IS AN INTEGRA-WELCH ALLYN COOLVENT HEADLIGHT, PRODUCT NUMBER 90230. ON (B)(6) 2013 CUSTOMER REPORTS THAT THERE WERE ACTUALLY TWO INCIDENCES. CUSTOMER REPORTS THIS UNIT AND 00MLX SERIAL # (B)(4) WERE BOTH USED AT THE SAME TIME FOR EACH OF TWO SEPARATE PROCEDURES AND TWO SEPARATE PROCEDURES AND TWO SEPARATE BURN EVENTS. SALES REPRESENTATIVE REPORTS THE BURNS THAT HE SAW, WERE THE RESULT OF THE CABLES BEING PULLED FROM THE LIGHT SOURCE BY THE CABLE ITSELF AND NOT THE STRAIN RELIEF. THE CABLE SNAPPED BACK AND BURNED PERSONS ABOUT THE WRISTS, NOT THE FINGERTIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60057 MLX 300W XENON LIGHTSOURCE NA FCW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1