BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIVA

    MDR report key: 21273014 · Received January 30, 2025

    Report

    Report Number
    21273014
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 6, 2025
    Report Date
    January 14, 2025
    Manufacturer
    HOLOGIC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: WHILE DOING THE TEST FIRE STEPS DURING SET-UP FOR A STEREOTACTIC BIOPSY, THE BIOPSY DEVICE DID NOT PASS THE TESTING PHASE. PRIOR TO USE OF BIOPSY NEEDLES, A SERIES OF SET-UP STEPS AND A TEST FIRE IS DONE. THIS NEEDLE WOULD NOT ADVANCE AS IT NORMAL DOES AND IT WAS GIVING THE PEARL MACHINE A RED ERROR LIGHT. THE NEEDLE WAS DISCONNECTED, AND A NEW NEEDLE WAS USED FOR THE EXAM. THIS NEW NEEDLE WAS TESTED AND PASSED SET-UP PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692032 EVIVA BREAST BIOPSY SYSTEM KNW HOLOGIC E24J30RC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female