BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19381444 · Received May 23, 2024

    Report

    Report Number
    9610595-2024-10455
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 17, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170339110
    PMA / PMN Number
    K051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 DEVICE WAS NOT RETURNED TO OLYMPUS. THE SUGGESTED EVENT WAS NOT CONFIRMED AS IT WAS NOT REPRODUCIBLE. THERE WAS A CONCERN THAT ACETONE MAY HAVE BEEN USED TO BLOW OUT SCOPES INSTEAD OF ALCOHOL, BUT IT WAS DETERMINED PROMPTLY THAT IT WAS, IN FACT, ALCOHOL THAT WAS USED. IT WAS CONFIRMED THAT THE USER DID NOT CONDUCT IMPROPER REPROCESSING. IT WAS CONFIRMED BY THE REPORTS THAT PERFORMANCE OF REPROCESSING ON THE DEVICE WAS SECURED BY FOLLOWING REPROCESSING STEPS IN ACCORDANCE WITH IFU. THE CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT THE VIDEOSCOPE HAD ACETONE BLOWN THROUGH THE SCOPE; HOWEVER, IT WAS LATER REPORTED THAT ALCOHOL WAS BLOWN THROUGH THE SCOPE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500993 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H180J 04953170339110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown