February 2024
Response to recent media coverage
October 2023
Response to New York Times coverage
August 2021
Statement on FDA Safety Communication from Aug. 20, 2021
Intuitive’s primary focus is patient safety. We recognize and support FDA’s important role in protecting and promoting public health, including its oversight of clinical trials.
Intuitive follows FDA regulation and guidance, and Intuitive’s ongoing U.S. clinical investigation on the safety and effectiveness of robotic-assisted surgery in prophylactic nipple-sparing mastectomy has been approved by the FDA under an Investigational Device Exemption.
The Safety Communication issued on August 20, 2021 by the FDA, is specific to the use and study of robotic-assisted surgery in mastectomy. It affirms that “RAS devices have been cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy and colectomy. These clearances are based on short term (30 day) patient follow up.”
The FDA has not evaluated robotic-assisted surgical devices for the prevention and treatment of cancer based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.
Intuitive believes that any treatment or medical intervention should be informed by discussions between surgeons, clinicians and patients that consider all options, the associated risks and benefits, the surgeon’s or clinician’s own training, experience and outcomes.
July 2021
Regarding recent media coverage
We want to correct a misleading assertion made in recent media reports about da Vinci surgical systems. Intuitive does not have the ability to remotely shut down a da Vinci surgical system during a procedure underway at a hospital.
For patient safety purposes, there are circumstances in which a da Vinci surgical system may automatically stop functioning if operated in an unsafe manner or if a serious error is detected. Further, we maintain robust cybersecurity controls that prevent access to the systems that could modify their behavior during surgery.
Intuitive values the safety and well-being of surgeons and their patients. “Patients first” is core to our mission and foundational to what we do, and why we do it.
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) or visit https://manuals.intuitivesurgical.com/market.
Individuals’ 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.
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.
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 healthcare professional regarding these and other potential risks.
Procedures using the Ion robotic bronchoscopy 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.
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.
Information provided by the Ion endoluminal system or its components should be considered guidance only and not replace clinical decisions made by a trained physician.
Da Vinci 5 system
For risks, cautions, and warnings and full prescribing information, refer to the associated da Vinci 5 Surgical System user manual(s).
Contraindication
Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.
Precaution for Representative Uses
The demonstration of safety and effectiveness for the representative-specific procedures was based on evaluation of the device as a surgical tool and 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 or condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.