Class 2 Device Recall da Vinci X/Xi EndoWrist Surgical System EndoWist Suction Irrigator

• Date Initiated by Firm: June 04, 2018
• Create Date: October 30, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0249-2020
• Recall Event ID: 81073
• 510(K)Number: K162973
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
• Code Information: Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: 800-876-1310
• Manufacturer Reason for Recall: The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.
• FDA Determined Cause: Process change control
• Action: On 06/04/2018, Medical Device Recall notices (Field Safety Notice Urgent Medical Device Correction- ISIFA2018-09-C) were emailed to U.S. consignees, and on 06/07/2018 notices were mailed via FedEx. Additionally on 06/08/2018 two (2) distributors received the notices via email and on 06/15/2018 two (2) EMEIA consignees received the notices by mail. The firm posted information regarding the voluntary field recall on their US Customer Portal on 06/04/2018. Customers were asked to: 1. Stop-use of the affected products for intra-cardiac procedures until further notice from the Recalling Firm. 2. Ensure surgeons and patient side assistants using the products have read and understand the content of the notification letter. 3. Complete the attached Acknowledgement Form and return it via fax or email to U.S. FAX +1(408)523-0619, or Scan and Email Recalls@intusurg.com or for further questions contact Customer Service at: -North and South America: 800-876-1310 Option 3 (4 am to 5 pm PST) -Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) 4. Please retain a copy of the Customer Notification and the Acknowledgement form on file.
• Quantity in Commerce: 3108 units (518 boxes of 6 units)
• Distribution: Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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