BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 15676986 · Received October 26, 2022

    Report

    Report Number
    3002808148-2022-03565
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    September 30, 2022
    Report Date
    December 19, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL 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 IMAGE ISSUE OCCURRED DUE TO IMPROPER DEVICE SETTINGS. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING VERBIAGE, WHICH MAY HAVE PREVENTED THE PHENOMENON: ¿REFER TO P132 ¿4.4 SYSTEM SETUP (CONNECTION SETTING) ¿PERIPHERAL (2)¿ TAB¿ SETTING ITEM>TYPE(PRINTER)>OEP-5>SELECT WHEN CONNECTING THE OEP-5.¿ 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 THERE WAS A NO IMAGE ISSUE. TAC ADJUSTED THE ASPECT RATIO TO 5:4, AND CUSTOMER WAS SATISFIED WITH THE IMAGE. CUSTOMER TRIED TO TAKE A PICTURE WITH THE SCOPE AND THE NO IMAGE ISSUE REMAINED. TAC CONFERENCED IN ANOTHER OLYMPUS TAC, TO ASSIST WITH THE OEP-5 PRINTER. CUSTOMER WAS INSTRUCTED TO TURN OFF IMAGER, TURN BACK ON, TURN OFF PRINTER AND PERFORM A HARD RESET. TROUBLESHOOTING WAS SUCCESSFUL IN RESOLVING CUSTOMER¿S ISSUE AND DEVICE RETURN IS NOT EXPECTED AT THIS TIME. 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 THAT THERE WAS A NO IMAGE ISSUE WHILE USING THE EVIS EXERA III VIDEO SYSTEM CENTER. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572508 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