BEUDAMED
    FDA Enforcement Class II Ongoing

    Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

    Recall: Z-1613-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1613-2023
    Event ID
    92115
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2023
    Initiation Date
    April 18, 2023
    Classification Date
    May 19, 2023
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

    Reason

    The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.

    Code Info

    UDI-DI: 04953170403019; Item code: Catalog N5786100 Lots Lower than H2530

    Distribution

    US Nationwide.

    Quantity

    309278 pieces