Class 2 Device Recall Intuitive da Vinci S

• Date Initiated by Firm: November 19, 2007
• Date Posted: January 31, 2008
• Recall Status: Terminated on August 27, 2008
• Recall Number: Z-0669-2008
• Recall Event ID: 46160
• 510(K)Number: K050369
• Product Classification: Cannula - Product Code NAY
• Product: Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road, Sunnyvale, CA
• Code Information: Lot Numbers Affected: SA070902, SA071101, and SA071401
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 950 Kifer Rd; Sunnyvale CA 94086-5206
• For Additional Information Contact: Mike Yramategui ; 408-523-2100
• Manufacturer Reason for Recall: Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannulae may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery.
• FDA Determined Cause: Other
• Action: On 11/19/07, the firm issued Urgent Device Recall Notification letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
• Quantity in Commerce: 89 units
• Distribution: Worldwide: USA including states of AZ, CA, CT, DC, GA, lA, MI, MN, NC, NJ, NV, OH, PA, SD, TX, and VA and country of Hong Kong
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NAY