BEUDAMED
    FDA Enforcement Class II Terminated

    Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.

    Recall: Z-1426-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1426-2013
    Event ID
    65072
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    October 13, 2011
    Classification Date
    May 29, 2013
    Termination Date
    May 30, 2013
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.

    Reason

    Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).

    Code Info

    NA - marketing and promotional only.

    Distribution

    USA Nationwide distribution

    Quantity

    2,423 consignee