BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLOGIC

    MDR report key: 12254301 · Received July 29, 2021

    Report

    Report Number
    MW5102887
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    July 27, 2021
    Report Date
    July 28, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STEREOTACTIC DEVICE MALFUNCTION; DURING STEREOTACTIC BREAST PROCEDURE, THE EQUIPMENT MALFUNCTIONED. CA TESTING WAS PERFORMED PRIOR TO THE COMMENCEMENT OF THE PROCEDURE, WHICH PASSED. AS PROCEDURE WAS BEING PERFORMED (AFTER NEEDLE WAS INSERTED INTO PT'S BREAST), THE EQUIPMENT FAILED TO TAKE ANY FURTHER EXPOSURES. ERROR CODES OCCURRED: "ERROR CODE 10, 2, 1." THE RESET BUTTON ALSO FAILED TO WORK. THE PROCEDURE WAS ABORTED; NO BIOPSY OR "CLIP PLACEMENT" WAS PERFORMED AND THE NEEDLE HAD TO BE MANUALLY REMOVED FROM THE PT. NO SIGNIFICANT PT INJURY OCCURRED DUE TO THIS EVENT. THE PT WILL REQUIRE THIS PROCEDURE TO BE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140798 HOLOGIC SYSTEM, X-RAY, MAMMOGRAPHIC IZH HOLOGIC, INC. MCP 6541

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention