Important safety information

Serious complications may occur in any surgery, including surgery with a da Vinci system, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection, and internal scarring that can cause long-lasting dysfunction/pain.

Risks specific to minimally invasive surgery, including surgery with a da Vinci system, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; a longer operative time, the need to convert to an open approach, or the need for additional or larger incision sites. Converting the procedure could result in a longer operative time, a longer time under anesthesia, and could lead to increased complications.

Contraindications applicable to the use of conventional endoscopic instruments also apply to the use of all da Vinci instruments.

For important safety information, including surgical risks and considerations, please also refer to www.intuitive.com/safety. For a product’s intended use and/or indications for use, risks, full cautions and warnings, please refer to the associated User Manual(s).

Individual outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, and/or surgeon experience.

Da Vinci Xi/X system precaution statement

The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.