BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOZART 3D SPECIMEN TOMOSYNTHESIS

    MDR report key: 16026855 · Received December 20, 2022

    Report

    Report Number
    MW5113921
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    September 21, 2022
    Report Date
    December 20, 2022
    Manufacturer
    KUB TECHNOLOGIES, INC.
    Product Code
    MWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    501
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING, STATING ONGOING PROBLEMS WITH THE MOZART SYSTEM DURING SURGICAL CASES. SHE STATES THAT A PATIENT WAS HAVING A PROCEDURE TO REMOVE BREAST CANCER TISSUE WHEN THE SYSTEM STARTED PERFORMING AN AUTOMATIC UPDATE. THIS RESULTED IN THE SCREENS "GOING BLACK", LOSS OF IMAGING, AND INABILITY TO IDENTIFY THE LOCATION OF IMPLANTED TISSUE MARKER CLIPS. AS A RESULT, THE PATIENT HAD TO RETURN TO HAVE A SECOND SURGERY TO REMOVE CANCEROUS TISSUE. SHE STATES THIS AUTOMATIC UPDATE PROBLEM HAS OCCURRED "AT LEAST TWENTY TIMES" AND RESULTS IN PROCEDURE INTERRUPTIONS, INCREASED SEDATION TIME FOR PATIENTS, AND PROLONGED SURGICAL CASES. REPORTER STATES THEY CONTACTED THEIR VENDOR TO ATTEMPT TO TROUBLESHOOT THIS PROBLEM BY REQUIRING A PASSWORD TO BE ENTERED PRIOR TO ANY UPDATES BEING INSTALLED, HOWEVER THIS TROUBLESHOOTING WAS UNSUCCESSFUL AND THE PROBLEM CONTINUED TO OCCUR DURING SURGICAL CASES. REPORTER STATES THAT MORE RECENTLY, THE VENDOR HAS APPLIED A "GROUP POLICY" TO PREVENT THIS AUTOMATIC UPDATE PROBLEM FROM ONCE AGAIN HAPPENING, AND SO FAR THIS HAS BEEN SUCCESSFUL. REPORTER STATES THAT, PER THE VENDOR, OTHER FACILITIES ARE EXPERIENCING SIMILAR PROBLEMS WITH THE MOZART SYSTEM. REPORTER STATES IS WITH (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727032 MOZART 3D SPECIMEN TOMOSYNTHESIS CABINET, X-RAY SYSTEM MWP KUB TECHNOLOGIES, INC. XPERT 42

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention TISSUE MARKER CLIPS.