Da Vinci Vision

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 instruments and accessories

It is the responsibility of the owner of the da Vinci surgical system to properly train and supervise its personnel to ensure that the instruments and accessories are properly cleaned, disinfected, and sterilized as required by the user’s manual. Da Vinci products should not be used in a clinical setting unless the institution has verified that these products are properly processed in accordance with the da Vinci system user manual.

When is the Firefly fluorescence imaging system used and what are the risks?

The da Vinci Fluorescence Imaging Vision System (Firefly fluorescence imaging) helps surgeons see vessels, blood flow (and related blood flow in tissue), and at least one of the major bile ducts around the liver.

To use Firefly, the surgeon injects a dye called ICG (IndoCyanine Green). This dye makes vessels, blood flow, related blood flow in tissue and bile ducts more visible during surgery under a special infrared light. It is required that standard white light (visible light) be used at the same time as the infrared light.

Deaths have been reported after an allergic reaction to the ICG injection. Allergic reactions, such as rashes and hives, have been reported in patients who may or may not have a history of being allergic to iodides.