BEUDAMED
    FDA Recall Terminated

    Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA

    Recall: Z-1179-2019 · Initiated March 8, 2019

    Recall

    Recall Number
    Z-1179-2019
    Event Number
    82451
    Firm
    Gyrus ACMI, Inc.
    FEI Number
    1037007
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 8, 2019
    Terminated
    May 8, 2020
    Address
    2925 Appling Rd, Bartlett, TN, 38133-3901

    Description

    Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA

    Reason

    Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

    Action

    Olympus issued a voluntary field action on March 8, 2019 via letter and reply form sent to all consignees informing them of the risk and requiring them to take action as follows: c. Consignees in the United States using MDCONSlOO consoles with the affected software wiIl be instructed to cease using the consoles. Replacement consoles that do not utilize the affected software will be made available on an interim basis until updated software is made available, and can be loaded into the affected consoles by Olympus Field Service personnel. d. OUS Consignees instructed to remove the affected blades currently in their possession from use, and returned to Olympus. Replacement blades will be sent to these consignees as soon as the process flow changes to the respective production lines are implemented, and inspections of blade inventory in Olympus' possession are completed. e. All affected consoles will be loaded with updated software as soon as it is available.

    Distribution

    Nationwide Foreign: Germany,Japan, Singapore

    Quantity

    502 OUS