Class 2 Device Recall da Vinci Xi Stainless Steel Handheld Camera Tray

• Date Initiated by Firm: December 19, 2019
• Create Date: June 09, 2020
• Recall Status: Terminated on August 31, 2023
• Recall Number: Z-2329-2020
• Recall Event ID: 85556
• 510(K)Number: K191043
• Product Classification: Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
• Product: STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
• Code Information: Model No. 400499-03; All Batch Numbers; UDI: 00886874115855
• 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: Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
• FDA Determined Cause: Device Design
• Action: The firm sent a Field Safety Notice, titled Urgent Medical Device Correction Letter - ISIFA2019-10-C to customers via FedEx starting on December 19, 2019. The letter informed customers that the firm had received complaints regarding small but detectable holes in the sterilization wrap used with da Vinci Xi 8 mm Endoscope Sterilization Trays (PN 400498-02) and Handheld Camera Sterilization Trays (PN 400499-03). Customers were informed that certain features on the trays, in combination with loading and unloading of wrapped trays into sterilizers, and stacking and unstacking of wrapped trays during handling and storage could lead to these holes and a potential breach of sterility and infection in patients. Instructions were provided on steps to be taken to mitigate the potential for development of small holes, to be used in conjunction with industry practice. This included: 1. to avoid dragging a wrapped tray when loading and unloading the sterilizer; 2. to lift trays instead of sliding or dragging on and off workbenches, shelves, and other horizontal surfaces, and 3. sites using sterilizers with interior brackets were advised that they should avoid dragging trays across interior brackets. Customers were also advised to continue to inspect wrapped trays prior to use per hospital policy, and to continue to follow instructions located in the da Vinci Xi Endoscope Reprocessing Instructions and da Vinci Xi Handheld Camera Reprocessing Instructions Addendum regarding stainless steel trays. Customers were requested to inform necessary hospital personnel about this issue, complete the attached Acknowledgement Form acknowledging they had received and read the notice, ensured all personnel were fully informed of the contents, would contact Intuitive with any questions, and would retain a copy of this letter for their files. The Acknowledgement Forms were to be faxed or emailed to Intuitive Surgical as follows: ATTN: REGULATORY COMPLIANCE FIELD ACTIONS Subject line for
• Quantity in Commerce: 16 Trays
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of Arkansas, Arizona, Alabama, Alaska, California, Connecticut, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Idaho, Kentucky, Kansas, Louisiana, Missouri, Michigan, Maryland, Mississippi, Minnesota, Montana, Maine, Massachusetts, Nevada, New York, North Dakota, Nebraska, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington and West Virginia. Multiple countries including Canada.
• 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 = KCT