BEUDAMED
    FDA Recall Open, Classified

    The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.

    Recall: Z-2835-2018 · Initiated May 17, 2018

    Recall

    Recall Number
    Z-2835-2018
    Event Number
    80691
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    May 17, 2018
    Address
    1266 Kifer Rd, Bldg 101, Sunnyvale, CA, 94086-5304

    Description

    The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.

    Reason

    An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.

    Action

    Intuitive Surgical notified customers via a "Field Safety Notice Urgent Medical Device Correction ISIFA2018-06-C da Vinci Xi Miscalibrated Endoscope Controller" letter. The letter provided: Reason for Field Action, Risk to Health, Affected Products (description, part number, serial number), Action taken by Intuitive Surgical, Actions to be taken by the Customer/ User, contact information for Further Information & Support, and an Acknowledgement Form.

    Distribution

    U.S.

    Quantity

    1