BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA

    MDR report key: 1242890 · Received November 19, 2008

    Report

    Report Number
    6000153-2008-07595
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    July 23, 2008
    Report Date
    October 21, 2008
    Manufacturer
    MPROC
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED A RELIABILITY NON-CONFORMANCE THOUGH A SPECIFIC ROOT CAUSE WAS NOT DETERMINED. A HIGH FORCE WAS REQUIRED TO DEPLOY THE NEEDLES. THERE WAS NEEDLE BLOCK WEAR ON THE GUIDE RAILS INSIDE THE HANDPIECE AND NEEDLE BLOCK SHAVINGS WERE PRESENT AROUND THE SCOPE TUBE AND FRONT STOP. THE WASHER WAS LOOSE ON THE BACK SIDE OF THE SHEATH BLOCK AND THE SHEATHS HAD SCRAPE MARKS FROM SCRAPING AGAINST THE NEEDLE GUIDE TUBES. THERE WAS NO FLUID EVIDENCE INSIDE THE PLASTIC HANDLE. THERE WAS EVIDENCE OF ADHESIVE INSIDE THE URETHRAL TUBE. RESULTS: NEEDLE BLOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE PROCEDURE, THE HANDLE STARTED "STICKING". THE CASE WAS COMPLETED USING ANOTHER HANDPIECE. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MPROC 8929 08D034V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention