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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65072
Product Type Devices
Status Terminated
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-10-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA Nationwide distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. NA - marketing and promotional only. Class II Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k). 2,423 consignee Z-1426-2013