BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA

    MDR report key: 1190560 · Received October 6, 2008

    Report

    Report Number
    6000153-2008-06358
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 9, 2008
    Manufacturer
    MPROC, VILLALBA
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADD'L INFO IS RECEIVED FROM THE HCP. THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, PROSTIVA RF MODEL 8929 HAND PIECE NEEDLE RETRACTION FAILURE (2008).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE, THE NEEDLES ON THE HANDPIECE WOULD NOT RETRACT. THE PT HAD MILD BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDPIECE. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MPROC, VILLALBA 8929 V130303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention