BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUPATH BIOPSY DEVICE

    MDR report key: 1081572 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01279
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER ALTHOUGH THE DEVICE EVALUATION HAS NOT BEEN COMPLETED AT THE TIME OF THIS FILING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING A PROSTATE BIOPSY PROCEDURE, WHILE OUTSIDE THE PT, THE NEEDLE ON THE TRUPATH BIOPSY DEVICE FIRED ON ITS OWN. THE DEVICE HAD SUCCESSFULLY TAKEN A COUPLE BIOPSIES PRIOR TO THIS EVENT. THE PHYSICIAN WAS ABLE TO RELOCK THE DEVICE AND OBTAIN ANOTHER SAMPLE, WHEN ONCE AGAIN, WHILE OUTSIDE THE PT, THE DEVICE FIRED ON ITS OWN, BUT THIS TIME THE DEVICE WOULD NO LONGER LOCK. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE WITH NO PT COMPLICATIONS. ADDITIONALLY, IT WAS REPORTED THAT THE HOSPITAL STAFF OPERATING THE DEVICE WERE UNHARMED BY THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUPATH BIOPSY DEVICE FCG BOSTON SCIENTIFIC CORPORATION M0065001151 11516379

    Patients

    Seq Age Sex Outcome Treatment
    1 70'S