BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 18486119 · Received January 10, 2024

    Report

    Report Number
    3002808148-2024-00347
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 26, 2023
    Report Date
    February 13, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION.   A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED.   THE CUSTOMER INFORMED THAT THE ISSUE WAS RESOLVED BY USING A DIGITAL VISUAL INTERFACE CABLE. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE IMAGE IS NOT DISPLAYED WITH SERIAL DIGITAL INTERFACE CONNECTION BECAUSE AN APPROPRIATE SERIAL DIGITAL INTERFACE VIDEO CABLE WAS NOT CONNECTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE VIDEO PROCESSOR HAD NO IMAGE. THE 3RD PARTY VIDEO CABLE ONLY WORKED WHEN IT WAS PLUGGED INTO THE COMPONENT PORTS ON BOTH THE LCD MONITOR AND THE VIDEO PROCESSOR. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THE CUSTOMER WAS ABLE TO FIND A DIGITAL VISUAL INTERFACE CABLE IN STOCK THAT WAS SUITABLE FOR THE LENGTH NEEDED TO PROVIDE GOOD VIDEO QUALITY. NO NEW PURCHASES ARE NEEDED. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551496 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OEV-262H