BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPULSE POWERSUITE 100 WATT

    MDR report key: 3131272 · Received January 8, 2006

    Report

    Report Number
    2914019-2006-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2006
    Date of Event
    October 26, 2005
    Report Date
    January 6, 2006
    Manufacturer
    LUMENIS (ISRAEL)
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS SERVICE FOUND THAT RELAY MIRRORS ON THE POWERSUITE SYSTEM WERE PITTED. PITTING OF THE RELAY MIRRORS CAUSES THE UNIT TO SHUT DOWN TO AVOID DAMAGE TO THE ASSOCIATED HOLMIUM A BRICK "DOWN" RESULTS IN LOWER POWER. THE DAMAGED RELAY MIRRORS WERE REPLACED BY LUMENIS SERVICE AFTER WHICH THE UNIT WAS READY FOR USE. THE END USER (HOSPITAL) DID NOT REPORT THE INCIDENT TO BE A SAFETY COMPLAINT TO THE OWNER OF THE POWERSUITE SYSTEM, SO THE COMPLAINT WAS NOT PREVIOUSLY INVESTIGATED AS POTENTIAL SAFETY COMPLAINT. LUMENIS NOTIFIED THE OWNER OF THE POWERSUITE REGARDING THE USER FACILITY MDR REPORT.

    Description of Event or Problem · 1

    CUSTOMER FILED USER FACILITY MDR STATING THAT DURING A HOLMIUM LASER PROSTATE VAPORIZATION, THE SIDE-FIRING HOLMIUM LASER FIBER WAS INSERTED AND THE BLADDER NECK AND THE SMALL MEDIAN LOBE WERE ABLATED. AT THIS POINT THERE WAS AN EQUIPMENT MALFUNCTION SUCH THAT THE LASER COULD NOT BE RESTARTED, THEREFORE, THE SCOPE WAS WITHDRAWN AND PROCEDURE CONVERTED OVER TO TUBP. THE POWERSUITE UNIT ASSOCIATED WITH THIS COMPLAINT IS A RENTAL UNIT. FDA MAILED A COPY OF THE USER FACILITY MDR TO LUMENIS POSTMARKED 12/21/2005. REF UF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPULSE POWERSUITE 100 WATT SURGICAL LASERS GEX LUMENIS (ISRAEL) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other NONE REPORTED