BEUDAMED
    FDA Recall Terminated

    da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.

    Recall: Z-2630-2017 · Initiated June 1, 2017

    Recall

    Recall Number
    Z-2630-2017
    Event Number
    77389
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 1, 2017
    Posted
    June 6, 2017
    Terminated
    October 2, 2017
    Address
    1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

    Description

    da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.

    Reason

    da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.

    Action

    Intuitive Surgical sent an Field Safety Notice letter dated June 1, 2017 to customers. The letter was sent electronically via through our da Vinci customer portal via email to the affected sites on June 1, 2017. Letters are sent to the da Vinci Coordinator, Recall Coordinator and/or Risk Management. The customer will receive a hard copy of this letter on June 6, 2017 via Fed Ex. The letter identified the affected product, problem and actions to be taken. For questions contact your Clinical Sales Representative.

    Distribution

    Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan

    Quantity

    10 units