BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENORX ENCORE MRI TROCAR TIP PROBE

    MDR report key: 5328882 · Received December 28, 2015

    Report

    Report Number
    5328882
    Event Type
    Malfunction
    Date Received
    December 28, 2015
    Date of Event
    November 19, 2015
    Report Date
    November 23, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR INC
    Product Code
    FCK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MRI BREAST BIOPSY. DURING THE SECOND SWEEP OF BREAST SAMPLE, THE BIOPSY NEEDLE WAS FELT TO HAVE BEEN RESISTANT TO ATTENDING PHYSICIAN. WHEN BIOPSY DEVICE WAS REMOVED, THE END WAS NOT ATTACHED TO BIOPSY TROCAR GUN. DR COULD SEE THE TIP AND REMOVED THE END PIECE FROM THE PATIENT'S BREAST WITH NO INJURY TO THE PATIENT. REMAINING STOCK OF INTRODUCERS WERE REMOVED FROM SHELVES AND WILL CALL AREA MANAGER TO REPLACE REMAINING STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854489 SENORX ENCORE MRI TROCAR TIP PROBE INSTRUMENT, BIOPSY, SUCTION FCK BARD PERIPHERAL VASCULAR INC VT15B0076

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR