BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 15576471 · Received October 11, 2022

    Report

    Report Number
    9610595-2022-02741
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 1, 2022
    Report Date
    November 9, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    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 REASON THE SCOPE WHICH WAS USED FOR A PATIENT WITH CREUTZFELDT-JAKOB DISEASE WAS LATER USED ON ANOTHER PATIENT WAS UNIDENTIFIED. THIS COMPLAINT IS CONSIDERED INFORMATION WITH NO EVIDENCE OF FAILURE OF AN OLYMPUS DEVICE. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿THE REPROCESSING MANUAL DESCRIBES ABOUT CREUTZFELDT-JAKOB DISEASE IN THE SECTION, ¿PRECAUTIONS¿.¿ THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO B5 AND G2. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, A SCREENING PROCEDURE WAS PERFORMED ON A PATIENT WITH CREUTZFELDT JAKOB DISEASE (CJD). THE SUBJECT DEVICE MAY HAVE BEEN USED ON ANOTHER PATIENT BEFORE THE CJD WAS DISCOVERED. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. THIS EVENT INCLUDES THREE REPORTS AS FOLLOWS: (B)(6): JF-260V, (B)(4). (B)(6) : GF-UCT260, (B)(4). (B)(6) : GIF-H290Z, (B)(4). THIS REPORT IS 1 OF 3 FOR (B)(6) : JF-260V, (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS RECEIVED: ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, IT WAS CONFIRMED THAT THE DETAILS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2897795 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. JF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown