BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALLISTO

    MDR report key: 5694212 · Received June 2, 2016

    Report

    Report Number
    5694212
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 25, 2016
    Report Date
    May 31, 2016
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    OBO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CALISTO MACHINE WAS PLACED IN ONE OF THE OPERATING ROOMS. THE SURGEON WAS NOT ABLE TO GET AN IMAGE. THE STAFF ATTEMPTED TO SOLVE THE ISSUES WITH MANY ATTEMPTS BUT WERE UNSUCCESSFUL. THE OTHER CALISTO WAS PLACED IN THE ROOM, BUT THEN ALL THE INFORMATION FROM THE USB PORT WAS LOST WHEN IT WAS PLACED IN THE FIRST CALISTO MACHINE. THE STAFF WENT BACK TO THE CLINIC TO INSTALL ALL THE PATIENT INFORMATION INTO THE USB PORT AND THEN COME BACK TO OPERATING ROOM, CAUSING A 30 MINUTE DELAY. THE SURGEON NOTIFIED THE PATIENT OF THE ISSUE. THE SURGERY THEN CONTINUED AS NORMAL. IT WAS LATER DETERMINED THAT THE SOFTWARE WAS NOT INSTALLED; THE VENDOR INSTALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350413 CALLISTO TOMOGRAPHY, OPTICAL COHERENCE OBO CARL ZEISS MEDITEC AG

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR