Class 2 Device Recall ingleSite Wristed Needle Driver

• Date Initiated by Firm: October 06, 2023
• Date Posted: November 28, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0406-2024
• Recall Event ID: 93301
• 510(K)Number: K152448
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
• Code Information: UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: Ian Purdy; 408-523-2100
• Manufacturer Reason for Recall: There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
• FDA Determined Cause: Process control
• Action: On October 24, 2023, Intuitive issued a "Urgent Medical Device Recall notification" to all affected consignees via E.Mail. Intuitive asked consignees to take the following actions: 1. Read and understand the contents of the letter. 2. Locate and return all affected lots of 478115-03 in your inventory via the standard RMA process by calling Intuitive Customer Service based on your region below. 3. Notify all surgeons, personnel, and sites using da Vinci X and da Vinci Xi Single Site Wristed Needle Driver, PN 478115-03 that they should review and understand the contents of this letter. 4. Complete the attached Acknowledgement Form immediately and return it via email to Intuitive as instructed on the form. a. Please retain a copy of this letter and the acknowledgement form for your files. 5. Inform Intuitive of any Adverse Events* or quality problems concerning the use of the subject device via the standard complaint process. 6. For Customers in the US: 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. a. Complete and submit the report Online Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. 8. Inform all affected personnel at your site who use da Vinci procedures when the return has been completed.
• Quantity in Commerce: 317 units
• Distribution: US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
• 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