BEUDAMED
    FDA Recall Terminated

    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.

    Recall: Z-1952-2018 · Initiated April 17, 2018

    Recall

    Recall Number
    Z-1952-2018
    Event Number
    79762
    Firm
    Gyrus Acmi, Incorporated
    FEI Number
    3003790304
    Product Code
    FAS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 17, 2018
    Terminated
    September 18, 2023
    Address
    136 Turnpike Rd, Southborough, MA, 01772-2118

    Description

    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.

    Reason

    There is a potential for the cord to spark and cause a fire.

    Action

    Notification letters were distributed on April 17, 2018. The letters instruct customers to perform the following: Immediately assess any affected product you have in stock and replace the IFU with the revised IFU. Also ensure that any potential users of the devices are aware of the additional warning in the revised IFU. Future versions of the IFU will include the warning. Remove and discard all cords in use greater than one year. If you need additional copies of the IFU, call your Olympus customer service representative at 1-888-524-7266 to arrange for them to be provided. Please note on the enclosed Reply Form that you have received this information. Fax the completed Reply Form to 484-896-7128 regardless of whether you have any affected inventory at your facility. In addition, if you may have further distributed this product, please identify your customers, inform them at once of this action, provide the revised IFU and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this letter. For further questions, please call (508) 804-2600.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Japan, Canada, Mexico, Australia, and EU.

    Quantity

    6447