BEUDAMED
    FDA Enforcement Class II Ongoing

    Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator

    Recall: Z-1071-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-1071-2024
    Event ID
    93732
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2024
    Initiation Date
    December 8, 2023
    Classification Date
    February 9, 2024
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator

    Reason

    Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.

    Code Info

    UDI: 04953170441271 All lot numbers

    Distribution

    US Nationwide distribution.

    Quantity

    24300 units (box of 20 pieces)