Class 2 Device Recall da Vinci Xi Surgical System

• Date Initiated by Firm: January 24, 2023
• Date Posted: March 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1262-2023
• Recall Event ID: 91505
• 510(K)Number: K131861 K171294
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
• Code Information: System REF: Serial Numbers/Cart REF/UDI-DI/Arm Serial Numbers: IS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093, IS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: Alex Mathews; 408-523-2100
• Manufacturer Reason for Recall: Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
• FDA Determined Cause: Component change control
• Action: On 01/24/2023, New Field Safety Notices were sent to customers. In addition, some customers received another notice informing them that additional preventative maintenance data would need to be collected by the recalling firm's field service personnel, to determine if additional devices were affected. On 1/27/2023, updated New Field Safety Notices were sent to two additional customers. Customers were asked to do the following: 1) Review this Field Safety Notification with all system users and place a copy of it with Instructions for use (IFU) of the system. 2) Complete and return the Acknowledgment Form via email to Recalls@intusurg.com The recalling firm will replace instrument arms found to be affected and will update the Preventive Maintenance Test to include the same analysis/method of processing Insertion Axis Friction Data that was used for determining the affected product for this Field Safety Notice so any new USM that may become susceptible will get addressed as part of the same. Customers with questions can contact customer service at: - US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. - Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com Taiwan: 886-2-2-27008181 (9am to 6:00pm CST) or CS.taiwan@intusurg.com
• Quantity in Commerce: 9
• Distribution: Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France
• 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