Marketed by Intuitive Surgical Systems, the da Vinci surgical system is considered a state-of-the-art robotic operating system which allows surgeons to perform surgeries by making a few small incisions. The da Vinci Surgical System can be used to perform a variety of surgeries including gynecological procedures, weight loss surgery, and general surgery.
The robot, which has increased vision, dexterity, and control, allows doctors to perform surgeries with minimal scarring, faster recovery times, decreased blood loss, lower risk of infection, and less pain. Additionally, the da Vinci surgical system allows the doctor to control the operation but with much smaller and more precise movements.
The Federal Drug Administration (FDA) later criticized Intuitive Surgical Systems for warning customers of the issues related to the da Vinci surgical system without first notifying FDA regulators. The company countered arguing that this information was “a reiteration of existing FDA-cleared labeling that reminded users on proper use.”
Unfortunately, as early as 2013, Intuitive Surgical Systems had to issue a statement that injury and complications from using the da Vinci surgical system were on the rise. Specifically, the company had to announce to their customers that certain models of the da Vinci's monopolar curved scissors had "micro-cracks that created a pathway for electrosurgical energy to leak into tissue during use and potentially cause thermal injury."
Although hospitals continue to use the da Vinci surgical robot, some patients claim there is a continued risk of injury. A class action lawsuit has been filed against the Intuitive Surgical Systems claiming that doctors were not sufficiently trained to use the device, the da Vinci surgical robot is a defective product, and that Intuitive Surgical Systems did not do enough to sufficiently warn of potentially life-threatening injuries when the da Vinci surgical robot was used.