BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSY INSTRUMENT

    MDR report key: 2212662 · Received August 11, 2011

    Report

    Report Number
    1036710-2011-00008
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    KNW
    PMA / PMN Number
    K974814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE USED DURING THE PROCEDURE HAS BEEN RECEIVED BY OUR FACILITY FOR REVIEW. THE CANNULA TIP IS CURLED BACK, AND THE STYLET IS BENT. THE LOT NUMBER REPORTED BY THE CUSTOMER WAS MANUFACTURED IN 2009. THE NEEDLE SET HAS BEEN REVISED SINCE THE REPORTED LOT NUMBER WAS MANUFACTURED. THIS REVISION ELIMINATED A PRE-BEND IN THE STYLET TIP AND MODIFIED THE SPECIMEN NOTCH FROM A CURVE TO A CHAMFER TO REDUCE THE RISK OF CANNULA DAMAGE. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    DURING A BREAST BIOPSY PROCEDURE, THE CUSTOMER STATES THAT THE TIP OF THE NEEDLE BENT INTO THE BREAST TISSUE OF THE PATIENT, CAUSING TISSUE DAMAGE AND PROLONGED BLEEDING DURING AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSY INSTRUMENT SUPERCORE BIOPSY INSTRUMENT KNW ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 701114090 92091VWW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other