BEUDAMED
    FDA Enforcement Class II Terminated

    URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

    Recall: Z-1251-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1251-2017
    Event ID
    75990
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 8, 2017
    Initiation Date
    December 12, 2016
    Classification Date
    February 24, 2017
    Termination Date
    February 26, 2018
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

    Reason

    Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.

    Code Info

    All serial numbers are affected.

    Distribution

    Distributed Nationwide

    Quantity

    3461 units distributed to US consignees