BEUDAMED
    FDA Recall Open, Classified

    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

    Recall: Z-0244-2023 · Initiated October 14, 2022

    Recall

    Recall Number
    Z-0244-2023
    Event Number
    91041
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    ONO
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 14, 2022
    Posted
    November 17, 2022
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

    Reason

    Due to a defect in the outer pouch sterile seal

    Action

    On 10/03/2022, the firm verbally notified affected customers and on 10/14/2022 sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customer informing them that Medtronic identified a breach to the sterile barrier of the outer pouch of specific lots of VCLAS 9735560 .4MM Core Fiber 10MM Tip products. Customer are instructed to: immediately identify and segregate affected products within your inventory. Medtronic will contact you to facilitate product replacement when unaffected product is available. Medtronic has determined that the inner pouches maintain sterility, accordingly, you may use segregated products ensuring the following sterile technique workflow is followed: 1. Open the affected outer pouch outside of the sterile field and remove the smaller internal pouches. 2. Per the Instruction for Use: Prior to use, examine the product packaging (in this instance the inner pouch) for damage, deterioration, and expired shelf life. If found, do not use the product. 3. Open the internal pouches using sterile technique and carefully transfer the sterile contents into the sterile field. For questions, contact Medtronic Technical Service at 1-888-826-5603 or email at [email protected]

    Distribution

    U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV.

    Quantity

    95 units