BEUDAMED
    FDA Enforcement Class II Ongoing

    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

    Recall: Z-1264-2022 · Reported June 22, 2022

    Enforcement

    Recall Number
    Z-1264-2022
    Event ID
    90195
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 22, 2022
    Initiation Date
    April 20, 2022
    Classification Date
    June 13, 2022
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

    Reason

    Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

    Code Info

    UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299

    Distribution

    CA FL MA MD MI NJ OH PR WI

    Quantity

    4 units