BEUDAMED
    FDA Enforcement Class II 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 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2380-2021
    Event ID
    88448
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    June 9, 2021
    Classification Date
    August 27, 2021
    Termination Date
    February 17, 2023
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    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.

    Code Info

    Lot number KR121617

    Distribution

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

    Quantity

    6 boxes (5 per/box)=30 units