BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1211843 · Received August 6, 2008

    Report

    Report Number
    1211843
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 6, 2008
    Manufacturer
    LASERSCOPE
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A PROSTATE VAPORIZATION PROCEDURE (PVP) AND THE LASER FIBER APPEARED TO BE FRAYED WHEN LOOKING AT IT THROUGH A VIDEO CAMERA. THE FIBER WAS REMOVED BY THE PHYSICIAN AND EXAMINED. THE FIBER STILL APPEARED TO BE FRAYED AND WAS REPLACED. THE DEFECTIVE FIBER WAS TAKEN OUT OF THE ROOM AND SENT TO THE MANUFACTURING COMPANY FOR FURTHER REVIEW OF THE PRODUCT. THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LASER, FIBER GEX LASERSCOPE 10-2079-B *

    Patients

    Seq Age Sex Outcome Treatment
    1 *