BEUDAMED
    FDA Enforcement Class II Ongoing

    Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.

    Recall: Z-0346-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0346-2024
    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

    Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.

    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): TJF-145 (04953170339950), TJF-150 (04953170307553), TJF-Q180V (04953170229503), TJF-Q190V (04953170405563).

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    0 units