Financial disclosure
The independent healthcare professionals in this material have received compensation from Intuitive for consulting and/or educational services.
Da Vinci 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
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.
Ion is for sale in the U.S.
Outside of the U.S., Ion may not have regulatory approvals in all markets. Please check with your local Intuitive representative.
Ion Important safety information
Risks associated with bronchoscopy through an endotracheal tube and under general anesthesia are infrequent and typically minor, and may include but are not limited to: sore throat, hoarseness, respiratory complications including dyspnea or hypoxemia, airway injury, bronchospasm, laryngospasm, fever, hemoptysis, chest or lung infection including pneumonia, lung abscess or an adverse reaction to anesthesia. Although rare, the following complications may also occur: bleeding, pneumothorax (collapsed lung), cardiac related complications, respiratory failure, air embolism, or death. As with other medical procedures, there may be additional risks associated with the use of general anesthesia and/or endotracheal intubation which are not listed above; you should consult a health care professional regarding these and other potential risks.
Procedures using the Ion Endoluminal System may be associated with longer procedure and/or longer anesthesia time.
Individuals’ outcomes may depend on a number of factors—including but not limited to—patient characteristics, disease characteristics, and/or physician experience.
Ion endoluminal system
The Ion Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
The Flexision Biopsy Needle is used with the Ion Endoluminal System to biopsy tissue from a target area in the lung.
The PlanPoint Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion Endoluminal System.
Firefly fluorescence imaging system
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.
Da Vinci SimNow
Da Vinci SimNow is intended to augment, not replace, existing training programs for the da Vinci surgical systems.
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.
Building a thoracic oncology programDr. Patrick Ross was an early pioneer in da Vinci thoracic surgery. Learn how he sees the da Vinci and Ion systems working together to improve lung cancer care.Sep 04, 2020 | 00:04:18
Right upper lobectomy with narrated lymph node dissectionDr. Elliot Servais explains how the da Vinci Xi allows him to perform complex minimally invasive lung resections and shares best practices for lymph node dissection in a right upper lobectomy.Dec 19, 2019 | 01:54:05
Lung-sparing segmentectomyDr. Harmik Soukiasian performs a lung-sparing segmenectomy using da Vinci Xi and SureForm stapling.Oct 17, 2023 | 00:08:37
Esophageal anastomosis compilationDrs. Cerfolio, Oh, Servais, and Soukiasian demonstrate esophageal anastomosis techniques using the da Vinci Xi, SureForm stapling, and Firefly fluorescence imaging.Oct 17, 2023 | 00:11:38
