BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME MAMMOTOME STEREOTACTIC PROBE 11 GAUGE

    MDR report key: 386282 · Received April 1, 2002

    Report

    Report Number
    1527736-2002-00631
    Event Type
    Malfunction
    Date Received
    April 1, 2002
    Report Date
    March 8, 2002
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (JUAREZ)
    Product Code
    KNW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SOME NEEDLESTICKS HAPPENED TO THE HOSPITAL PERSONNEL DURING REMOVAL OF THE MST11 FROM THE FISHER TABLE, AFTER THE BIOPSY. THE RESPONSIBLE OF THE IEO TECHNICAL DEPARTMENT, SAYS THAT AFTER THE BIOPSY THE OPERATOR MUST HANDLE A COMPONENT THAT INCLUDES THE NEEDLE WITHOUT ANY PROTECTION FROM ACCIDENTAL NEEDLESTICKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME MAMMOTOME STEREOTACTIC PROBE 11 GAUGE BREAST CARE KNW ETHICON ENDO-SURGERY, INC. (JUAREZ) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other