BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH POWER HOLMIUM LASER

    MDR report key: 824634 · Received March 2, 2007

    Report

    Report Number
    MW1042125
    Event Type
    Malfunction
    Date Received
    March 2, 2007
    Date of Event
    January 26, 2007
    Report Date
    February 21, 2007
    Manufacturer
    FORTEC MEDICAL
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER TURP SURGERY COMPLETED THE FORTEC MEDICAL TECHNICIAN DISCOVERED A LASER BURN ON THE OUTSIDE OF THE CYSTOSCOPE 1/2 INCH FROM THE TIP. THE SCOPE FITS INSIDE A SHEATH AND THE SCOPE DOES NOT EXTEND PAST THE END OF THE SHEATH. THE SIDE FIRING LASER FIBER IS EXTENDED PAST THE TOP OF THE SHEATH WHEN IN USE. IT APPEARS THE FIBER WAS ACTIVATED WHILE INSIDE THE SHEATH RESULTING TO DAMAGE TO THE SCOPE. THERE WOULD NOT HAVE BEEN ANY DEFLECTION OF THE LASER BEAM BECAUSE IT WAS INSIDE OF THE SHEATH. THERE WAS NO APPARENT INJURY TO THE PT NOTED. CYSTOSCOPE - ACMI M3-30A GOLD, SHEATH - ACMI CLS-23, FIBER - BOSTON SCIENTIFIC DUOTOME SIDELITE 550, REF # 840-846, UPN # M0068408460, LOT # 45611006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH POWER HOLMIUM LASER HIGH POWER HOLMIUM LASER GEX FORTEC MEDICAL SEE NARRATIVE ABOVE *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR