January 2025
Intuitive Statement on Favorable Ruling in Antitrust Case
As a matter of law, the court found in Intuitive’s favor on all of SIS’s antitrust claims. This judgment recognizes the central role that Intuitive’s commitment to patient safety plays, which is expressed through the design, testing and validation of our surgical systems and EndoWrist instruments. We support healthy, lawful competition, while honoring our responsibility to protect patient safety and provide surgeons with safe and proven tools and technologies.
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 da Vinci surgery, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs and conversion to other surgical techniques which could result in a longer operative time and/or increased complications. For summary of the risks associated with surgery refer to www.intuitive.com/safety.
For product intended use and/or indications for use, risks, cautions, and warnings and full prescribing information, 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), except for radical prostatectomy which was evaluated for overall survival, 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 Endoluminal system
As with any bronchoscopic procedure under general anesthesia, serious complications may include bleeding, pneumothorax (collapsed lung), cardiac-related complications, respiratory failure, air embolism, or death. For summary of the risks associated with bronchoscopy refer to www.intuitive.com/safety.
For risks, cautions, and warnings and full prescribing information, refer to the associated Ion System 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 physician experience.
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) or visit https://manuals.intuitivesurgical.com/market.
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.