BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA

    MDR report key: 1133588 · Received August 20, 2008

    Report

    Report Number
    6000153-2008-04968
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    MPROC, VILLALBA
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE, THE "TRIGGER STOPPER" OF THE HANDPIECE BROKE. IT RESULTED IN MAXIMUM NEEDLE DEPLOYMENT OF 22MM INSTEAD OF THE REQUIRED 12MM. THE HANDPIECE WAS REPLACED. THE MEDTRONIC REP CONFIRMED THAT THE HEALTHCARE PROVIDER WAS ABLE TO RETRACT THE NEEDLES AND REMOVE THE HANDPIECE WITHOUT ANY ISSUES. THE PT WAS FINE AFTER THE PROCEDURE. HE HAS A F/U APPOINTMENT IN A COUPLE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MPROC, VILLALBA 8929 V120086

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK