BEUDAMED
    FDA Recall Terminated

    Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy.

    Recall: Z-0747-2012 · Initiated November 28, 2011

    Recall

    Recall Number
    Z-0747-2012
    Event Number
    60548
    Firm
    Olympus America Inc.
    FEI Number
    2429304
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 28, 2011
    Posted
    January 13, 2012
    Terminated
    March 1, 2013
    Address
    3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610

    Description

    Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy.

    Reason

    Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100.

    Action

    Olympus America Inc. sent an URGENT: MEDICAL DEVICE CORRECTION ACTION" letter dated November 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. A questionnaire was attached to the letter for customers to complete and return via fax at 484-896-7128. Contact the firm at 484-896-5000 for questions regarding this notice.

    Distribution

    Nationwide Distribution.

    Quantity

    245