BEUDAMED
    FDA Recall Open, Classified

    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

    Recall: Z-1264-2022 · Initiated April 20, 2022

    Recall

    Recall Number
    Z-1264-2022
    Event Number
    90195
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FGB
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 20, 2022
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    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.

    Action

    Olympus notified Urgent Medical Device Correction letter on 4/20/22 via email. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. The model and serial number can be found on the device as illustrated. 2. An Olympus representative will contact you to make arrangements for return of your affected device. Olympus will repair your unit free of charge. In the meantime, follow the instruction manual for inspection of the device before use. Should any irregularities be identified, including a loose parts, do not use the device and contact Olympus for repair. 3. Olympus will arrange for a service loaner in an effort not to disrupt clinical care. Contact me directly at 647-999-3203 or at [email protected] for any additional information or support concerning this matter.

    Distribution

    CA FL MA MD MI NJ OH PR WI

    Quantity

    4 units