BEUDAMED
    FDA Recall Terminated

    Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA22067A. Working element for endoscopic diagnosis and treatment in urological and gynecological applications.

    Recall: Z-0828-2012 · Initiated December 27, 2011

    Recall

    Recall Number
    Z-0828-2012
    Event Number
    60772
    Firm
    Olympus America Inc.
    FEI Number
    2429304
    Product Code
    KNS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 27, 2011
    Posted
    January 20, 2012
    Terminated
    December 21, 2013
    Address
    3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610

    Description

    Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA22067A. Working element for endoscopic diagnosis and treatment in urological and gynecological applications.

    Reason

    Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements

    Action

    Olympus America Inc. sent an "URGENT: MEDICAL DEVICE WITHDRAWAL" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to inspect their inventory for the affected product and discontinue use of any affected product discovered. Customers should contact the Gyrus ACMI Customer Service Department at 1-888-524-7266 for credit or replacement of the product. Additionally, an Olympus Working Elements Withdrawal form was enclosed for customers to complete and fax to 484-896-7128. Contact the firm at 484-896-5688 for questions regarding this notice.

    Distribution

    Nationwide Distribution-including Washington, D.C. and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, and WI.