BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 1982738 · Received December 7, 2010

    Report

    Report Number
    1221336-2010-00007
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    September 30, 2010
    Report Date
    December 7, 2010
    Manufacturer
    INTEGRA LUXTEC
    Product Code
    FCW
    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 ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH REPORT (B)(4) FORWARDED BY THE FDA REPORTS: "THIS IS A DIRECT LARYNGOSCOPY CASE. THE LARYNGOSCOPE WAS IN THE PT'S MOUTH FOR LENGTHY PERIOD FOR PROCEDURE. THE DR NOTICED THE SCOPE ITSELF WAS GETTING HOT. NO BURN NOTICED, BUT HAD THE POTENTIAL. WE TOOK THE CORD FROM THE SCOPE INTO A HEADLIGHT BOX. WE HAVE BRAND NEW HEADLIGHT BOXES WITH NEW BULBS AND HIGHER INTENSITY LIGHT. SUGGESTED TO TURN DOWN THE INTENSITY OF THE LIGHT WHICH THEY DID AND THE SURGEON THOUGHT THAT THIS HELPED. DEVICE MALFUNCTION, THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." ORIGINAL INTENDED PROCEDURE, DIRECT LARYNGOSCOPY WITH BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MLX 300W XENON LIGHTSOURCE NA FCW INTEGRA LUXTEC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR