BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 16142505 · Received January 11, 2023

    Report

    Report Number
    3002808148-2023-00335
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 8, 2022
    Report Date
    February 24, 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
    AL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON 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. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE FAULTY PATIENT BOARD SET COULD NOT BE DETERMINED. ACCORDING TO THE INSTRUCTION MANUAL, IT WAS CONFIRMED THAT THE PATIENT CIRCUIT BOARD HAS SCOPE CONTROL FUNCTION AND IMAGE DATA TRANSMISSION FUNCTION. THE DESIGN OF THE PATIENT CIRCUIT BOARD WAS CHANGED ON APRIL 16, 2018 TO ADDRESS THE IMAGE ISSUES ASSOCIATED WITH IT AND THE 180 SCOPE. THE DEVICE WAS MANUFACTURED BEFORE THE DESIGN CHANGE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR INVESTIGATION. UPON EVALUATION OF THE DEVICE, THE REPORTED ISSUE WAS CONFIRMED DUE TO A FAULTY PATIENT BOARD SET. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME, HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE EVIS EXERA III VIDEO SYSTEM CENTER IS UNABLE TO DISPLAY IMAGE WITH THE SMALL BAWLS SCOPES. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900198 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 MAJ-1430.