Class 2 Device Recall EndoWrist MCS Tip Cover Accessory

• Date Initiated by Firm: September 23, 2011
• Date Posted: May 29, 2013
• Recall Status: Terminated on May 30, 2013
• Recall Number: Z-1425-2013
• Recall Event ID: 65073
• 510(K)Number: K050005
• Product Classification: System,surgical,computer controlled instrument - Product Code NAY
• Product: Tip Cover Accessory, 8 MM, MCS, box of 10; ; Product Usage:; The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
• Code Information: Model numbers: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09.
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 100; Sunnyvale CA 94086-5304
• For Additional Information Contact: Richard Reeves; 408-523-2244
• Manufacturer Reason for Recall: Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
• FDA Determined Cause: Device Design
• Action: Intuitive Surgical sent an Important Product Notification letters dated October 10, 2011 to all affected customers. A second letter was sent to those that had not responded on December 4, 2011. The letters identified the affected product, problem, and actions to be taken, The letter included recommendations and suggestions for proper use and prevention of damage to the Tip cover during surgery. Also attachments include recommendations and further information for the following areas: avoid instrument collisions; carefully install tip cover; straighten wrist prior to removal; inspect cannula prior to use and do not exceed maximum monopolar cautery settings. Attached is a list of validated ESU settings and suggestions and instruction on being aware of critical anatomy in contact with the instrument and to change the tip cover in cases with extended cautery use. Questions may be referred to Customer service at 1-800-876-1310 in the US and at + 41 21 821 2020 or +800-0821-2010.
• Quantity in Commerce: 50,000 boxes of 10 tip covers
• Distribution: Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
• 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 and Original Applicant = INTUITIVE SURGICAL, INC.