BEUDAMED
    FDA Enforcement Class II Ongoing

    GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    Recall: Z-0416-2024 · Reported December 6, 2023

    Enforcement

    Recall Number
    Z-0416-2024
    Event ID
    93335
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aizu Olympus Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 6, 2023
    Initiation Date
    October 16, 2023
    Classification Date
    November 29, 2023
    Address
    3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, Japan

    Description

    GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    Reason

    Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

    Code Info

    UDI-DI 04953170305290 Serial Numbers 2515895, 2312905, 2628532

    Distribution

    Domestic distribution to FL, KY, MA, NJ, NY, and PA

    Quantity

    24 incorrectly repaired units