BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME STEREO PROBE - 8 GAUGE

    MDR report key: 1595198 · Received February 1, 2010

    Report

    Report Number
    MW5014622
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    November 11, 2009
    Report Date
    February 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC. J&J CO.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A BREAST CORE BIOPSY UTILIZING AN 8 GAUGE SAMPLE PROBE AND TISSUE MARKER, BROUGHT BY A VENDOR. ON (B) (6) 2009, THE PATIENT HAD AN EXCISIONS BX. A PIECE OF THE TISSUE MARKER'S PLASTIC APPLICATOR WAS FOUND IN THE BREAST NEAR THE MARKER. IT HAD APPARENTLY BEEN SHEARED OFF BY THE 8 GAUGE PROBE ON (B) (6) 2009. IT WAS REPORTED TO THE BREAST CENTER MANAGER BY THE SURGEON. FOLLOW UP WAS OBTAINED FROM THE SPECIMEN AND REPORTED TO THE VENDOR AND RISK MANAGEMENT. THE PATIENT HAD NO SIGN OF INFECTION VISUALLY OR IN THE PATHOLOGY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME STEREO PROBE - 8 GAUGE STERO BREAST BIOPSY PROBE - 8 GAUGE KNW ETHICON ENDO-SURGERY, INC. J&J CO. MST 8 SAMPLE FROM VENDOR

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other