BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA

    MDR report key: 1070198 · Received July 3, 2008

    Report

    Report Number
    6000153-2008-03790
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 15, 2008
    Report Date
    June 6, 2008
    Manufacturer
    MPROC, VILLALBA
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE, AN ERROR MESSAGE OCCURRED WITH THE PROSTIVA DEVICE AFTER THE NEEDLES WERE DEPLOYED. THE GENERATOR WAS UNPLUGGED AND PLUGGED BACK IN SEVERAL TIMES. THE SITUATION COULD NOT BE RESOLVED AND THE PROCEDURE WAS ABORTED. THE HCP CONFIRMED THAT THE PATIENT IS OK AND IS RESCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MPROC, VILLALBA 8929 V065185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention