BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUPATH BIOPSY DEVICE

    MDR report key: 1181038 · Received September 23, 2008

    Report

    Report Number
    3005099803-2008-04774
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A PROSTATE BIOPSY PROCEDURE WHILE USING TRUPATH BIOPSY DEVICES, THE PHYSICIAN EXPERIENCED MISFIRING WITH 2 DEVICES. IN BOTH INCIDENTS THE DEVICES WERE COCKED AND LOADED (THE YELLOW INDICATOR WAS PRESENT) AND THE NEEDLE FIRED WITHOUT PRESSING THE BUTTON THE FIRST NEEDLE TOOK 3 SAMPLES BEFORE MISFIRING AND THE SECOND NEEDLE TOOK 1 SAMPLE BEFORE MISFIRING. BOTH NEEDLES MISFIRED DURING ARMING OUTSIDE OF THE PATIENT WITH NO HARM TO THE PATIENT OR USER. THE PHYSICIAN PROCEEDED TO COMPLETE THE PROCEDURE WITH A THIRD OF THE SAME DEVICE, THE PATIENT IS REPORTED TO BE "FINE". NOTE: THIS REPORT IS BEING FILED FOR ONE OF THE TWO DEVICES THAT MISFIRED, REFER TO MFR# 3005099803-2008-04773 FOR THE REPORT ON THE OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUPATH BIOPSY DEVICE FCG BOSTON SCIENTIFIC CORPORATION M0065001151 11161806

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK