BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT LASER

    MDR report key: 1083421 · Received July 16, 2008

    Report

    Report Number
    1083421
    Event Type
    Malfunction
    Date Received
    July 16, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 16, 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

    PVP SCHEDULED IN CYSTO ROOM. WHEN DOCTOR WOULD FIRE THE LASER, THE VIDEO SCREEN WOULD COMPLETELY WHITE-OUT. HE WAS UNABLE TO VISUALIZE THE PROSTATE TISSUE AS HE WAS VAPORIZING. DURING THE PROCEDURE, A CALL WAS MADE TO LASERSCOPE. THE REP RECOMMENDED SWAPPING DISKS, CAMERAS, LIGHT SOURCES AND FINALLY LASER FIBERS. NONE OF THE RECOMMENDATIONS CLEARED THE PROBLEM. DOCTOR ALSO FELT THAT THE OUTPUT FROM THE LASER MACHINE WAS NOT ADEQUATE TO VAPORIZE THE TISSUE. THE APPEARANCE OF THE LASERED TISSUE WAS NOT WHAT IT NORMALLY LOOKED LIKE AFTER BEING LASERED. HE ALSO TRIED A 30 WATT SETTING TO COAG AND HE WAS UNABLE TO GET THE BLEEDING TO STOP. THE PROCEDURE TURNED INTO A TURP. THE OUT-PATIENT WAS ADMITTED AS A 24-HOUR OBSERVATION WITH A 3 WAY FOLEY CATHETER. APPARENTLY, ANOTHER MD HAS HAD THE SAME TYPE OF PROBLEMS. HE DID NOT FEEL THE TISSUE WAS VAPORIZING AS EASILY AND THEY WERE EXPERIENCING SOME OF THE SAME VIDEO WHITE-OUTS. AT THE TIME, NOT RECOGNIZED AS THE SAME TYPE OF PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT LASER LASER, SURGICAL GEX LASERSCOPE KTP 803 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *