Statement on da Vinci X
Intuitive India is committed to patient safety. It is vital to our culture, our technology, and the service we provide to our customers.
Intuitive India is proud that the da Vinci X robotic-assisted surgical system is available to surgeons in India and around the world to provide their patients with safe, effective, and well-established minimally invasive care.
The da Vinci X surgical system is a robotic-assisted platform used globally to perform minimally invasive surgeries with enhanced precision, flexibility, and control. Since its introduction in 2017, the da Vinci X system has enabled surgeons and hospitals to safely and effectively expand access to high-quality, minimally invasive, robotic-assisted surgery to more patients at a lower cost.
The da Vinci X system first received regulatory clearance by the U.S. Food and Drug Administration in 2017. That same year, the da Vinci X system received CE marking from the European Union regulatory authorities. These approvals validate the system’s compliance with gold-standard regulations and stringent international safety and quality standards.
Surgeons and hospital staff around the world trust the da Vinci X system, evidenced by more than 770,000 procedures performed globally, on more than 1,000 systems across six continents.
Intuitive manufactures all da Vinci X systems at the same location in the United States, where they meet international quality management, safety and performance standards
Reconditioning is a thorough process in which each system undergoes rigorous testing and certification according to ISO13485 quality management and applicable product standards for testing robotic-assisted surgical systems. Only a few components of previous versions of da Vinci systems are used in the construction of the da Vinci X system. However, newly manufactured reconditioned da Vinci X systems have not been previously owned or used before import into India or any other country where they are used, and much of the system, including all patient-contact components, are new.
Intuitive India adheres to Indian regulatory standards, including those from the Ministry of Environment, Forest, and Climate Change’s Hazardous and Other Wastes Rules, the Directorate General of Foreign Trade guidelines, and Medical Device Rules.
Since its inception, Intuitive has facilitated over 14.4 million procedures globally with da Vinci systems, including more than 100,000 procedures in India. More than 38,000 scientific publications validate Intuitive’s da Vinci systems’ safety, effectiveness, and contribution to improved clinical outcomes.