BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 17681811 · Received September 5, 2023

    Report

    Report Number
    3002808148-2023-09351
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 14, 2023
    Report Date
    November 16, 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
    NY, US
    Reporter Occupation
    NURSE
    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. ADDITIONAL INFORMATION ADDED TO FIELD H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE FACTS OBTAINED FROM THE INVESTIGATION, IT IS PRESUMED THAT [NO IMAGE] OCCURRED DUE TO WRONG INPUT SELECTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED THE EVIS EXERA III VIDEO SYSTEM CENTER IS NOT DISPLAYING AN IMAGE ON THE OEV-191H / OEV 262H MONITORS. THROUGH TROUBLESHOOTING, THE CABLING WAS VERIFIED: SERIAL DIGITAL INTERFACE (SDI) OUT 1 GOES TO OEV-191H VIDEO IN PORT (CANNOT SELECT SDI ON THE OEV-191H), COMP OUT GOES TO GMED, THE MONITOR OUT GOES TO THE WALL, THE OEV-262H HAS A CABLE CONNECTED TO THE VIDEO IN, AND THERE IS A RED, GREEN, BLUE (RGB) CABLE HANGING FROM THE CEILING (NOT CONNECTED). THE CUSTOMER WAS INSTRUCTED TO SWITCH THE CABLE FROM SDI OUT 1 TO COMP OUT ON THE CV-190, THEN TO TAKE THE CABLE FROM COMP OUT AND CONNECT TO SDI OUT 1 ON THE CV-190, AND THERE WAS NOW AN IMAGE ON THE OEV-191H. THE CUSTOMER WAS THEN INSTRUCTED TO TAKE THE CABLE ON THE OEV-262H AND MOVE IT FROM VIDEO INTO SDI 1 IN, AND IT HAD AN IMAGE. THE ISSUE WAS RESOLVED; THEREFORE, THE DEVICE WILL NOT BE 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 EVIS EXERA III VIDEO SYSTEM CENTER IS NOT DISPLAYING AN IMAGE ON THE OEV-191H / OEV 262H MONITORS. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378634 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 OEV-191H - HIGH DEFINITION 19 INCH LCD MONITOR.| OEV-262H - 26 INCH SURGICAL MONITOR.