BEUDAMED
    FDA Recall Open, Classified

    Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

    Recall: Z-1815-2022 · Initiated August 12, 2022

    Recall

    Recall Number
    Z-1815-2022
    Event Number
    90788
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 12, 2022
    Posted
    September 26, 2022
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

    Reason

    An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

    Action

    Olympus issued Urgent Medical Device Recall Letter on 8/12/22 to Surgical Department Risk Management. Letter states reason for recall, health risk and action to take: 1. Immediately locate any product with affected lot numbers listed in this communication. See Attachment 2 for pictures showing the location of lot numbers on the package. 2. Call your Olympus customer service representative at 1 800 848 9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0412 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Contact directly at (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.

    Distribution

    Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA

    Quantity

    44 units (5/box); 133 units (5/box) OUS