BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1251-2017 · Initiated December 12, 2016

    Recall

    Recall Number
    Z-1251-2017
    Event Number
    75990
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FBN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 12, 2016
    Terminated
    February 26, 2018
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    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.

    Action

    Olympus sent an Urgent Medical Device Safety Notice dated December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus that were taken to address the issue. Consignees were asked to inspect their inventory for the specified device, review the enclosed Instructions for Safe Use, which provided instructions to assist with understanding the Warnings and Cautions. You can contact our Technical Assistance Center (TAC) at 1-(800) 848-9024, option 1, to answer any questions.

    Distribution

    Distributed Nationwide

    Quantity

    3461 units distributed to US consignees