BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA

    MDR report key: 2973765 · Received April 18, 2007

    Report

    Report Number
    2649622-2007-03224
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Report Date
    March 19, 2007
    Manufacturer
    MNPRO
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS DETERMINED A RELIABILITY NON-CONFORMANCE ON THE HANDPIECE. THE POSTS ON THE NEEDLE BLOCKS HAD BROKEN OFF, CAUSING THE NEEDLES TO FAIL TO RETRACT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HCP THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE THE HANDPIECE BROKE AND THE NEEDLES WOULD NOT RETRACT. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDPIECE. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MNPRO 8929 V021103

    Patients

    Seq Age Sex Outcome Treatment
    1