BEUDAMED
    FDA Enforcement Class II Ongoing

    Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.

    Recall: Z-0332-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0332-2024
    Event ID
    93222
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aizu Olympus Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2023
    Initiation Date
    September 25, 2023
    Classification Date
    November 17, 2023
    Address
    3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, N/A, Japan

    Description

    Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.

    Reason

    Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

    Code Info

    Model Number (UDI-DI): ENF-T3 (04953170307188), ENF-VT2 (04953170339509), ENF-VT3 (04953170411526).

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    46 units