—#181456

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.

FDA product code: KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K191043
Affected lot / code info: Model No. 400499-03; All Batch Numbers; UDI: 00886874115855

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-12-19
Terminated: 2023-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.