BEUDAMED
    FDA Recall Terminated

    da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Surgical, Inc. Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    Recall: Z-1202-2012 · Initiated February 6, 2012

    Recall

    Recall Number
    Z-1202-2012
    Event Number
    61156
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 6, 2012
    Posted
    March 13, 2012
    Terminated
    May 9, 2012
    Address
    1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

    Description

    da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Surgical, Inc. Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    Reason

    The holding brake, a component of the da Vinci S Surgical System, may allow passive uncontrolled motion due to gravity during specific power-off conditions.

    Action

    Intuitive Surgical sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 3, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provided new instructions for use. Additionally, a Device Correction Response Form was enclosed for customers to complete and return via fax to 408-523-1390. Contact Intuitive Surgical Customer Service at 1-800-876-1310 for questions regarding this notice.

    Distribution

    Worldwide Distribution.

    Quantity

    1966 systems are in commerce at hospital locations.