Class 2 Device Recall daVinci XI Sureform 60 Reload

• Date Initiated by Firm: July 01, 2019
• Create Date: May 05, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1891-2020
• Recall Event ID: 85256
• 510(K)Number: K173721
• Product Classification: Stapler, surgical - Product Code GAG
• Product: daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
• Code Information: Lot numbers: T10180615; T10180924; T10181003; T11181003; T10181010; T10181016; T10181029; T10181107; T10181109; T10181113
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: Mark Johnson; 408-523-2100
• Manufacturer Reason for Recall: The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
• FDA Determined Cause: Employee error
• Action: On July 1, 2019 , the firm sent an "Urgent Medical Device Recall" notification to affected customers concer the da Vinci Xi SureForm 60 Stapler Reload. In addition to informing customer's about the recalled product, the firm asked customers to take the following actions: 1. Intuitive Surgical requests customers locate the affected Stapler Reloads at each site and return them. 2. Inform necessary personnel when corrective action has been completed. 3. If customer has distributed any affected product to other sites, please forward this notice to all related parties. 4. 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/ 5. Complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form, or complete using the da Vinci online resource tool.
• Distribution: Worldwide distribution - US Nationwide including in the states of AL, AK, AZ, AR, CA, CO, CT, DE, D.C., FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI and the countries of Australia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Switzerland, 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 = GAG