The maker of the popular da Vinci robotic surgery system is playing defense as federal regulators, noting an increase in adverse events associated with the technology, queried surgeons who use it.
“There has been no increase in the rates of adverse events or death for da Vinci Surgery,” a spokeswoman for Intuitive Surgical said in a statement. “The clinical evidence shows that da Vinci is safer than open surgical alternatives in many of the common procedures in which it is used.”
In January, the Food and Drug Administration sent a survey to hospitals that participate in the FDA's medical product safety network. The survey is voluntary and will collect confidential information from surgeons about their perspectives on the challenges of using the da Vinci Surgical System.