BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 19201499 · Received April 29, 2024

    Report

    Report Number
    9610595-2024-08827
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 19, 2024
    Report Date
    May 24, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K220587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THERE WAS A DIFFERENCE IN RECOGNITION ON DEVICE HANDLING OR REPROCESSING STEPS BETWEEN OLYMPUS RECOMMENDATION AND THE USER. OLYMPUS EXPERT STAFF CONDUCTED TRAINING ON PROPER REPROCESSING FOR THE USER. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: PREVENTIVE MEASURE IS DESCRIBED IN IFU: TJF-Q190V REPROCESSING MANUAL 5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED DURING AN ONSITE VISIT, THE USER FACILITY STAFF WAS NOT USING SUCTIONING ON THEIR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SCOPE DURING REPROCESSING WHICH RESULTED IN INCORRECT REPROCESSING. NO PATIENT INFECTIONS OR INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492564 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown