BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 15198220 · Received August 10, 2022

    Report

    Report Number
    3002808148-2022-00765
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 15, 2022
    Report Date
    October 14, 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
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CALLED INTO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) PERSONNEL TO REPORT HER EVENT. DURING THE CALL, THE CUSTOMER NOTED THAT HER CV-190 TOWER WAS NOT DISPLAYING AN IMAGE, ONLY COLOR BARS. TAC RECOMMENDED RESEATING THE CABLES AT THE BACK OF THE UNIT. THE CUSTOMER RESEATED THE CABLES, AND THE IMAGE WAS DISPLAYING PROPERLY. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE PRIOR TO THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 PROBLEM WAS ABLE TO BE RESOLVED THROUGH TROUBLESHOOTING. THE DEFINITIVE ROOT CAUSE OF THE COLOR BARS COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE COLOR BARS DISPLAYED DUE TO A CONNECTION FAILURE OF THE LIGHT SOURCE CABLE BETWEEN THE DEVICE AND LIGHT SOURCE. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN THE STAFF PLUGGED IN THE FACILITY¿S BF-XP190 SCOPE TO THE EVIS EXERA III VIDEO SYSTEM CENTER, THERE WAS NO IMAGE PRESENT, ONLY COLOR BARS ON THE DISPLAY. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. THIS REPORT IS BEING SUBMITTED FOR THE VIDEO SYSTEM CENTER DEVICE, FOR THE COMPLAINT CAPTURING THE BF-XP190 SCOPE DEVICE, PLEASE SEE REPORT WITH PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211148 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 BF-XP190