BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 18874871 · Received March 11, 2024

    Report

    Report Number
    3002808148-2024-02265
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Report Date
    March 27, 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
    SC, 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 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS NOT POSSIBLE TO ESTABLISH THE ROOT CAUSE. THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED THAT THE VIDEO SYSTEM CENTER USING DIGITAL VISUAL INTERFACE, HAD NO IMAGE. IT WAS ADVISED TO CONNECT A NEW DIGITAL VISUAL INTERFACE CABLE OR TRY A SERIAL DIGITAL INTERFACE CABLE WITH THE MONITOR. THE CUSTOMER REPLACED DIGITAL VISUAL INTERFACE CABLE AND THE ISSUE WAS RESOLVED. THE DEVICE WAS NOT RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER USING DIGITAL VISUAL INTERFACE, HAD NO IMAGE WHEN CONNECTED TO THE STORZ MONITOR. THE ISSUE OCCURRED DURING THE INSTALLATION OF THE HYLAND BOX. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968913 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