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 SP system (TORS and URO)
The safety and effectiveness of this device for use in the performance of general laparoscopic surgery procedures have not been established. This device is only intended to be used for single port urological procedures and for transoral otolaryngology surgical procedures in the oropharynx for benign tumors and malignant tumors classified as T1 and T2 with the da Vinci EndoWrist SP instruments and the da Vinci SP surgical system (SP1098).
Product training
Training provided by Intuitive is limited to the use of the da Vinci surgical system and does not replace the necessary medical training and experience required to perform surgery. The da Vinci surgical system should be used only by surgeons who have received specific training in its use. Before performing any procedure using a da Vinci system, physicians are responsible for receiving sufficient training and proctoring to ensure that they have the skill and experience necessary to protect the health and safety of their patients.