BEUDAMED
    FDA Adverse Event Other Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 1912750 · Received November 1, 2010

    Report

    Report Number
    1221336-2010-00006
    Event Type
    Other
    Date Received
    November 1, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 1, 2010
    Manufacturer
    INTEGRA LUXTEC
    Product Code
    FCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE RISK MGR REPORTS THAT DURING A SURGICAL PROCEDURE, A LUXTEC MLX LIGHT SOURCE (SN (B)(4)) WAS USED TOGETHER WITH A WELCH ALLYN FIBEROPTIC LIGHT CABLE AND WELCH ALLYN HEADLIGHT FOR ILLUMINATION. AT THE END OF THE PROCEDURE, WITH THE MLX STILL POWERED ON, AN RN PULLED THE FIBEROPTIC CABLE FROM THE MLX LIGHT SOURCE. ACCORDING TO THE RISK MGR THE INJURY OCCURRED TO THE "THUMB OF THE PERSON REMOVING LIGHT CABLE FROM LIGHT SOURCE. LIGHT SOURCE ADAPTOR WAS HOT AND AS RN BRUSHED AGAINST IT, IT CAUSED A BURN." THE ADAPTER/CABLE ENDTIP IS METAL. THE INJURY WAS NOT TREATED. NO INTERNAL REPORT WAS SUBMITTED AT THE HOSPITAL AND NO EQUIPMENT WAS RETURNED. ALL EQUIPMENT INVOLVED HAD BEEN PREVIOUSLY USED.

    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