BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DUODENOSCOPE ED-580XT

    MDR report key: 12092057 · Received June 30, 2021

    Report

    Report Number
    3001722928-2021-00012
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    July 12, 2019
    Report Date
    June 30, 2021
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    UDI-DI
    04547410359282
    PMA / PMN Number
    K191747
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FUJIFILM MEDICAL SYSTEMS U.S.A., INC. INSPECTED THE SCOPE AND FOUND NO FAULTS. THE INSPECTORS WERE UNABLE TO CONFIRM OR REPRODUCE THE EVENT. THE SCOPE WAS INSERTED INTO THE PATIENT'S ABDOMINAL CAVITY VIA A TROCAR. PER THE INSTRUCTION MANUAL, THE SCOPE CAN ONLY BE INSERTED PER-ORALLY. THEREFORE, IT WAS DETERMINED THAT THE SCOPE WAS USED OFF-LABEL. THE TROCAR HAD A DIAMETER OF 15MM, WHILE THE SCOPE WITH THE DISTAL CAP ATTACHED HAD A MAXIMUM DIAMETER OF 14.9MM. FUJIFILM BELIEVES IT IS LIKELY THAT THE CAP WAS DISLODGED DUE TO FRICTION WHEN WITHDRAWING THE SCOPE OUT OF THE TROCAR. THIS ISSUE WAS INITIALLY IDENTIFIED AS A NON-REPORTABLE EVENT. DURING A FUJIFILM INTERNAL REVIEW OF THEIR ADVERSE EVENT REPORTING PROCEDURE, IT WAS DETERMINED THAT THIS EVENT SHOULD BE REPORTABLE TO FDA.

    Description of Event or Problem · 1

    DURING AN INTRA-OPERATIVE ERCP AND WHILE WITHDRAWING THE SCOPE THROUGH A 15MM TROCAR, THE DISTAL END CAP WAS DISLODGED AND FELL BACK INTO THE PATIENT'S ABDOMINAL CAVITY. THE SURGEON WAS ABLE TO REMOVE THE CAP EASILY WITH A GRASPER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991692 FUJIFILM DUODENOSCOPE ED-580XT DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-580XT N/A 04547410359282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention