BEUDAMED
    FDA Recall Open, Classified

    ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C

    Recall: Z-2415-2024 · Initiated June 21, 2024

    Recall

    Recall Number
    Z-2415-2024
    Event Number
    94885
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    June 21, 2024
    Posted
    July 23, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C

    Reason

    Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery

    Action

    Olympus issued URGENT: MEDICAL DEVICE REMOVAL Letter on 6/21/24. Letter states reason for recall, health risk and action to take: An Olympus representative will reach out to you to coordinate a repair to replace the power supply on your affected ESG-410 unit(s). Technical analysis of this issue performed by Olympus has determined that when the device is successfully powered on, it will work within specification. Therefore, you may continue to use your ESG-410 generator until the power supply is replaced. To minimize procedural delays, power on the generator prior to starting the procedure and, whenever possible, have a replacement device available. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. If you have further distributed this product, identify your customers, and forward them this notification. 3. Acknowledge receipt of this letter through the Olympus web portal: a. Go to https://olympusamerica.com/recall Olympus requests that you report any complaints, including the ESG-410 generator not powering on, to the Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1). If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 from Monday through Friday, 9 am to 5 pm EDT, or by e-mail at [email protected].

    Distribution

    US Nationwide distribution.

    Quantity

    86