BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 16670629 · Received April 3, 2023

    Report

    Report Number
    3002808148-2023-03266
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 7, 2023
    Report Date
    May 15, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170215513
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 IT IS LIKELY THE REPORTED ISSUE WAS CAUSED BY A FAULTY POWER SUPPLY. HOWEVER, THE SPECIFIC CAUSE OF THE FAULTY POWER SUPPLY WAS NOT ESTABLISHED AT THIS TIME. 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. 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 II VIDEO SYSTEM CENTER POWER BUTTON FAILURE WAS NOTED DURING PREPARATION FOR USE, PRIOR TO DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY PROCEDURE. THE SAME DEVICE WAS USED TO COMPLETE THE OPERATION WITH NO MORE THAN A 10 MINUTE DELAY. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, INTERMITTENT POWER SUPPLY WAS OBSERVED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT INSPECTION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534294 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ SHIRAKAWA OLYMPUS CO., LTD. CV-180 04953170215513

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown