BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRU PATH BIOPSY NEEDLE

    MDR report key: 1140644 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04172
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED, THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A TRUPATH BIOPSY NEEDLE WAS USED DURING A TRANSRECTAL PROSTATE BIOPSY PROCEDURE UNDER ULTRASOUND GUIDANCE ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DOCTOR REPORTED TO THE MEDICAL ASSISTANT THAT A FEW CORES WERE OBTAINED AND THEN THE DEVICE MALFUNCTIONED. IT AUTOMATICALLY TRIGGERED ON ITS OWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU PATH BIOPSY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M0065001151 11527254

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR