Class 2 Device Recall da Vinci Xi Surgical System, IS4200

• Date Initiated by Firm: April 11, 2019
• Create Date: May 05, 2020
• Recall Status: Terminated on April 08, 2024
• Recall Number: Z-1897-2020
• Recall Event ID: 83482
• 510(K)Number: K171294
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are four USM per da Vinci X surgical system.
• Code Information: UDI: 00886874114216 Device Listing: D295931 Serial Numbers: SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, SL0369
• Recalling Firm/ Manufacturer: Intuitive Surgical Inc; 950 Kifer Rd; Sunnyvale CA 94086-5206
• For Additional Information Contact: 800-876-1310
• Manufacturer Reason for Recall: Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
• FDA Determined Cause: Process control
• Action: On 04/11/2019, the firm sent an "Urgent Medical Device Correction" notifications via FedEx to its customers informing them that the Recalling Firm has become aware that specific Surgical Systems arms have the potential to encounter friction in specific instrument arm orientations. As a result, sluggish, jerky, or hesitating motion may be experienced at the instrument tip and/or resistance felt in the hand controls. To correct this issue, a Recalling Firm's representative will schedule a site visit to perform evaluations on their systems. Based on the results of the evaluation, any necessary corrections will be prioritized appropriately. In addition: Customers are informed and instructed that If any of instruments arms exhibit sluggish, jerky, or hesitating motion, or if you feel significant resistance from the hand controls with no interference between arms/instruments, contact the da Vinci Surgical Technical Assistance Team (dVSTAT) as soon as possible. General Acknowledgement 1. Forward this letter to your Risk Manager, OR Director, Biomedical Engineering staff, and other members of your medical staff who perform da Vinci procedures. 2. If available, please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 3. In the event the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax to Intuitive as instructed on the form. 4. Please retain a copy of this letter and the acknowledgement form for your files. representatives will be available by phone to answer any questions related to this Medical Device Correction. An Intuitive representative will schedule a site visit with your hospital to perform the inspection and provide any potential correction activity for the instrument arms of your system(s). If you need further information or support concerning this Medical Devic
• Quantity in Commerce: 270 USMs on a combination of 100 unique systems (4 USM per system)
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the 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