BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 17687678 · Received September 5, 2023

    Report

    Report Number
    3002808148-2023-09415
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 8, 2023
    Report Date
    November 9, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE IMAGE ISSUE WAS CAUSED BY IMPROPER HANDLING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. AFTER TROUBLE SHOOTING, THE DEVICE IS NOW WORKING AND WILL NOT BE RETURNED. INVESTIGATION INDICATES THAT THE RGB/S CABLE WAS NOT CONNECTED CORRECTLY, THE INPUT SELECT PARAMETER ON THE OEP-5 WAS SET TO SDI INSTEAD OF THE COMPONENT, THE KEYBOARD WAS IN DVR MODE INSTEAD OF PRINTER MODE. ONCE THE SETTINGS WERE CHANGED AND THE CABLING ISSUE WAS CORRECTED, THE A16 ERROR WAS RESOLVED. THE CUSTOMER SHUT OFF BOTH THE CV-190 AND THE CLV-190, REMOVED THE SCOPE, CLEANED THE CONTACT POINTS ON THE SCOPE WITH AN ALCOHOL PREP PAD, WAITED FOR IT TO DRY, CONNECTED THE SCOPE, AND POWERED EVERYTHING BACK ON. THE IMAGE CAN BE SEEN NOW, AND THE SYSTEM IS WORKING AS EXPECTED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III VIDEO SYSTEM CENTER DISPLAYED ERROR CODE A16 (ANNOTATION PRINTING HAD FAILED) AND DISPLAYED NO IMAGE. THE ISSUE WAS FOUND DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870080 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CV-190 CLV-190