Da Vinci Instruments

“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.