Da Vinci Instruments
Robotic instruments designed to enable precision beyond the limits of the human hand
“Patients first” has always been core to our mission. Patient safety, product efficacy, and delivering improvements in clinical outcomes guide the design, testing and manufacture of our surgical systems, instruments and accessories.
With these objectives in mind, we have designed and rigorously tested and validated our EndoWrist instruments with usage and reprocessing limits intended to provide consistent product performance from the first use to the last.
We are aware that certain third parties have sought to offer products or services to healthcare providers that would modify some of our instruments to extend their use. It is our understanding that such modifications constitute remanufacturing under FDA regulations and require 510(k) clearance from FDA.
We recognize the role that third-party medical device servicers have come to play in the medical device ecosystem, and we support healthy, lawful competition in the marketplace. We also have a responsibility to protect patient safety and provide customers with proven, safe and effective tools and technologies. The remanufacturing of EndoWrists is performed by third parties that are not affiliated with Intuitive, and we are not privy to their testing protocols, verifications and validations, remanufacturing processes, or quality controls, among other things. Therefore, Intuitive will not bear responsibility for instruments that are remanufactured by a third party, or for harms or damages caused by the use of such instruments.
However, Intuitive will not void its service contract with, cease doing business with, or consider it a breach of contract by a customer in the United States who chooses to purchase remanufactured instruments that have been remanufactured by a third party pursuant to and in compliance with a 510(k) clearance or equivalent granted by the FDA.
As of March 1, 2023, Intuitive is not aware that FDA has granted 510(k) or equivalent clearance to any party to remanufacture any instruments for use with 4th generation da Vinci technology, including the da Vinci X, Xi and SP systems. Outside of the US, Intuitive is also not aware that any regulatory bodies have granted clearance to any party to remanufacture any instruments for da Vinci systems. For more information about 510(k) clearances granted by FDA, please refer to FDA’s publicly available searchable database.
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 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.
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.
Da Vinci Single-Site for the Xi system (complete indication)
The safety and effectiveness of the da Vinci Xi Single-Site system for use in the performance of general laparoscopic abdominal surgery or general gynecological surgery procedures have not been established. The da Vinci Single-Site instruments and accessories are only intended to be used for single incision laparoscopic cholecystectomy, benign hysterectomy, and salpingo-oophorectomy with the da Vinci Single-Site instruments and the da Vinci Xi surgical system (IS4000). There may be an increased risk of incision-site hernia with single-incision surgery. Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for robotic-assisted surgery with da Vinci systems, including surgery with da Vinci systems with Single-Site instruments.