BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 19475760 · Received June 6, 2024

    Report

    Report Number
    9610595-2024-11395
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Report Date
    June 25, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170229503
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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. IT HAS BEEN OVER 13 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. THE INVESTIGATION ALSO FOUND THAT THE LIGHT GUIDE LENS HAD A CRACK. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: PHYSICAL STRESS WAS APPLIED TO DISTAL END DURING USER HANDLING, LEADING TO THE SUGGESTED EVENT. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: USER MAY REDUCE/PREVENT OCCURRENCE OF THE SUGGESTED EVENT BY HANDLING THE DEVICE IN ACCORDANCE WITH IFU BELOW. -DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR. ALSO, DO NOT BEND, PULL, OR TWIST THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING INSPECTION OF THE DEVICE, THE ADHESIVE BETWEEN THE DISTAL END AND SERVER PLUG-IN OF THE DUODENOVIDEOSCOPE WAS CRACKED AND HAS A GAP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980247 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q180V 04953170229503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown