Class 2 Device Recall Da Vinci Xi 8mm SureForm 30 instruments

• Date Initiated by Firm: October 07, 2022
• Date Posted: November 30, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0340-2023
• Recall Event ID: 91080
• 510(K)Number: K211997
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B
• Code Information: Model Name / Model Number / UDI-DI Code: Da Vinci Xi 8mm SureForm 30 instruments 488530-10 10886874121723 Da Vinci Xi 8mm SureForm 30 Grey Reload 48230M-02 10886874121938 Da Vinci Xi 8mm SureForm 30 White Reload 48230W-02 10886874121921 Da Vinci Xi 8mm SureForm 30 Blue Reload 48230B-02 10886874121914 All Serial Numbers
• 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: Potential staple deployment failure and device fragment generation
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 10/07/2022, Intuitive Surgical communicated an "Urgent Product Safety Notice" email to "STOP USE of da Vinci Xi 8mm SureForm 30 Stapler Instruments (488530-10) and Reloads (48230M-02, 48230W-02, 48230B-02)" and informing customers that there is a potential to transect targeted tissue without stapler formation that could result in bleeding and potential to generate fragments when using these products. On or about 10/25/2022, the firm sent an "Urgent Medical Device Removal" Letter via FedEx that informed their customers of the STOP USE. Customers are instructed to: Locate and return all affected products, as listed above, in their inventory via the standard RMA process by calling Intuitive Customer Service at (800) 876-1310, Option 3, 4 AM to 5 PM PST. If they have shared these products with other sites, make sure appropriate staff at that site receive and understanding this notification so that they locate and return their affected product. Customers may continue to use the da Vinci 12mm SureForm 45/60 instruments and reloads, as well as EndoWrist Stapler instruments and reloads, as these instruments are not impacted by this issue and use a different technology to effect stapler formation. For questions or further information: Contact their Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: - US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com
• Quantity in Commerce: 160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads
• Distribution: U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. O.U.S.: None
• 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