BEUDAMED
    FDA Recall Open, Classified

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    Recall: Z-0264-2025 · Initiated September 4, 2024

    Recall

    Recall Number
    Z-0264-2025
    Event Number
    95477
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 4, 2024
    Posted
    October 30, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    Reason

    There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).

    Action

    An URGENT: MEDICAL DEVICE CORRECTIVE ACTION notification letter dated 10/1/24 was sent to customers. Actions Required: Our records indicate that your facility has received one or more affected ESG-410 (SEP) units. An Olympus representative will reach out to you to coordinate a mutually convenient time to complete a software update on your affected ESG-410 (SEP) unit(s). You may continue to use your ESG-410 (SEP) generator until the software update is completed. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. " Go to https://olympusamerica.com/recall Enter the recall number "0457 " Complete the form as instructed. 3. Olympus s record of the completed software upgrade to your ESG-410 (SEP) generator(s) will serve as the acknowledgment of this field corrective action for your facility 4. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including the ESG-410 generator system error E1226 "Could not write to Audio Buffer , or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at [email protected].

    Distribution

    US Nationwide.

    Quantity

    279 units