da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460

As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation.

On 03/17/2022, the firm sent an Urgent Medical Device Correction letter informing customers of a potential for injury associated with the stapler instruments if target tissue fails to remain in place with the jaws of the stapler during the stapler firing sequence. This phenomenon is referred to as a tissue pushout event. As the staple firing sequence progresses, the target tissue is transected but the target tissue is not approximated due to lack of staple engagement with the tissue. This type of event may result in un-approximated tissue and occurs when attempting to cross over existing staple lines in the creation of a continuous staple line. Place this letter with the User Manual. Notify all surgeons and personnel using the Surgical System to review and understand contents of this letter and reacquaint themselves by reading the instructions, warnings, and cautions in the SureForm Instruments and Accessories User Manual Addendum. Customers can continue to use their instruments by following instructions: Use caution when unable to avoid crossing over existing staple lines and continue to adhere to all existing warnings and cautions found in the SureForm Instruments and Accessories User Manual Addendum. If a tissue pushout event is occurring, users may limit unapproximated tissue by pressing the emergency stop button (on Surgeon Console or Patient Cart helm), after which the SureForm stapler can be safely unclamped from the tissue using the Manual Release Knob. For further assistance, contact Clinical Sales Representative or Customer Service at: -US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4AM to 5PM PST) or mail: [email protected] -Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +4121 821 2020 (8AM to 6PM CET) or [email protected] -South Korea: 02-3271-3200 (9AM to 6PM KSTJ) or [email protected]