BEUDAMED
    FDA Recall Terminated

    Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC

    Recall: Z-2380-2021 · Initiated June 9, 2021

    Recall

    Recall Number
    Z-2380-2021
    Event Number
    88448
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 9, 2021
    Terminated
    February 17, 2023
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC

    Reason

    Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.

    Action

    Olympus issued Urgent Medical Device Recall Letter on June 9th 2021 via Federal Express two day mail. Letter states reason for recall, health risk and action to take: 1. Immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization to return any affected product. at no charge to you. Olympus will issue a credit or replacement to your facility for your 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 Recall-0395 and provide your contact information as indicated in the portal. In addition, if you have further distributed this product, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Contact me directly at 484-896-5688 or at [email protected] for any additional information concerning this matter.

    Distribution

    US Nationwide distribution in the states of CA, GA, MN, TN.

    Quantity

    6 boxes (5 per/box)=30 units