BEUDAMED
    FDA Enforcement Class II Ongoing

    Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.

    Recall: Z-0347-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0347-2024
    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

    Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.

    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): URF-P6 (04953170340802), URF-P6R (04953170340833).

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    1577 units