BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTIVA

    MDR report key: 1012966 · Received March 13, 2008

    Report

    Report Number
    6000153-2008-01215
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 11, 2008
    Manufacturer
    MPROC, VILLALBA
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    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 ADDITIONAL INFO IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE THE NEEDLES ON THE PROSTIVA HANDPIECE FAILED TO RETRACT. IT WAS NOTED THAT THE HANDLE FELT LIMP AND INOPERABLE. THE PT'S URETHRA WAS TORN AND REQUIRED A LARGER THAN USUAL CATHETER TO STOP THE BLEEDING. ON FOLLOW-UP, THE PT HAD NO LASTING ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MPROC, VILLALBA 8929 V05178

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention