BEUDAMED
    FDA Recall Terminated

    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

    Recall: Z-2629-2017 · Initiated April 19, 2017

    Recall

    Recall Number
    Z-2629-2017
    Event Number
    77297
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GCP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 19, 2017
    Terminated
    October 1, 2018
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

    Reason

    Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

    Action

    Olympus sent an Urgent Medical Device Removal Notice dated April 26, 2017, to affected customers to inform them of the issue. The notice identified the issue, the actions to be taken by the end user. It advised that customers discontinue use of any affected electrodes if found, contact Olympus Customer Care Center and they will provide instructions on how to return the affected product as well get a free replacement. Customer were instructed fax the completed reply from to 484-896-7128. Customer with questions should call 484-896-5688. For questions regarding this recall call 484-896-5000.

    Distribution

    Nationwide Distribution

    Quantity

    1264 units