BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1724935 · Received June 10, 2010

    Report

    Report Number
    MW5016335
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LNK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF PROSTATITIS & URINARY RETENTION. PT HAVING A LASER TUR DONE USING LASER FIBERS THROUGH A LASER CYSTOSCOPE. USING 80 WATTS THE BLADDER NECK AND MEDIAN BAR WAS LASED. USING 100 WATTS THE LATERAL LOBES WERE THEN LASED. THE FIRST TWO FIBERS WERE DEFECTIVE AND APPROPRIATE THERAPY WAS NOT COMPLETED UNTIL THE THIRD FIBER WAS USED (FROM A DIFFERENT LOT). BLACK SEDIMENT AND SPOTS OF BLACK METALLIC NOTED WITH THE DEFECTIVE FIBERS. THE HOLMIUM LASER WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC DUOTOME LASER FIBER LNK BOSTON SCIENTIFIC 99591009

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other