BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 3050360 · Received April 8, 2013

    Report

    Report Number
    1222895-2013-00011
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    April 5, 2013
    Manufacturer
    INTEGRA BURLINGTON MA INC
    Product Code
    FCW
    PMA / PMN Number
    K081477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH # 2300460000-2013-8029 INITIALLY REPORTS: WHEN IT WAS PULLED OUT AT THE END OF USE, WE NOTICED THE END OF THE CABLE WAS BURNED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: MICRODIRECT PHRYNGOSCOPY WITH INJECTION OF 100 INTERNATION UNITS OF BOTULINUM TOXIN. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). ON (B)(6) 2013, CUSTOMER REPORTS THAT HOW LONG LIGHT SOURCE WAS ON IS NOT KNOWN, HOWEVER, FROM INCISION TO DRESSING WAS ONLY 38 MINUTES. LIGHT INTENSITY - NOT KNOWN. BIOMED TESTED THE UNIT AND FOUND: LAMP HAD 952 HRS. UNIT HAD 1288 HRS. BIOMED OPENED THE UNIT UP TO FIND THE LENS OUT OF ITS SOCKET. LIGHT OUTPUT WAS 130.4 LUX. BIOMED REPLACED LAMP, THE LAMP MEASURES 513 LUX. BIOMED REPLACED LENS AS WELL. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144389 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA BURLINGTON MA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR