Class 2 Device Recall da Vinci Xi

• Date Initiated by Firm: December 23, 2021
• Create Date: March 01, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0702-2022
• Recall Event ID: 89274
• 510(K)Number: K140553 K162411
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
• Code Information: UDI: 00886874112588 L10210114 L10210115 L10210122 L10210125 L10210128 L10210204 L10210205 L10210211 L10210212 L10210215 L10210216 L10210217 L10210218 L10210219 L10210225 L10210226 L10210301 L10210304 L10210305 L10210308 L10210309 L10210316 L10210317 L10210318 L10210321 L10210322 L10210513 L10210514 L10210520 L10210521 L10210527 L10210528 L10210529 L10210715 L10210716 L10210717 L10210718 L10210719 L10210720 L10210722 L10210723 L10210731 L10210801 L10210803 L10210805 L10210806 L10210807 L10210808 L10210809 L10210812 L10210813 L10210819 L10210924 L10210925 L10210926 L10210930 L11210111 L11210316 M10210330 M10210331 M10210405 M10210408 M10210409 M10210412 M10210415 M10210416 M10210422 M10210423 M10210429 M10210430
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: 408-523-2100
• Manufacturer Reason for Recall: Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 12/23/21 recall notices were mailed to customers who were asked to do the following: 1. Inform necessary hospital personnel about this issue. 2. Locate all affected devices at your site and return to the recalling firm. 3. Inform affected personnel when the requested actions have been completed. 4. Complete and return the attached Acknowledgement Form 5. Please retain a copy of this letter and the acknowledgement form for your files. If you need further information or support contact your Clinical Sales Representative or contact Intuitive Customer Service: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@instusurg.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: 886-2-27008181 (7:30am to 5:30pm CT) or CS.Taiwan@intusurg.com Distributors were asked to provide their customers with the information found in the recall notice; the notice the recalling firm sent to their customers was included as an attachment. Distributors are to collect the affected cannula reducers and return them to the recalling firm. Distributors were asked to complete and return a recall response form. They were also asked to follow-up with their customers who don't respond to the recall notice at least three times.
• Quantity in Commerce: 149,646 reducers
• Distribution: Worldwide distribution - US Nationwide distribution in the states of California, Wisconsin, Virginia, Ohio, Texas, New York, Nevada, Connecticut, New Jersey, Massachusetts, Georgia, Florida, Indiana, North Carolina, Missouri, Pennsylvania, Michigan, Oregon, Kentucky, Hawaii, Tennessee, Alabama, Nebraska, Maryland, Oklahoma, Colorado, Arkansas, Arizona, Kansas, Illinois, South Carolina, Minnesota, North Dakota, Iowa, Louisiana, Washington, Delaware, Mississippi, New Mexico, District of Columbia, Idaho, New Hampshire, Rhode Island, West Virginia, South Dakota, Alaska, Maine, Utah, Montana, Vermont, Wyoming, Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Monaco, Netherlands, Norway, Poland, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, 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 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 and Original Applicant = INTUITIVE SURGICAL, INC.