In the letter, the FDA says it wants to "better understand users' perspectives on the different challenges raised when using the da Vinci surgical system interface for performing surgery versus conventional surgical procedures." Among the questions to surgeons:
The FDA says the survey "is intended to help us better understand [users'] perspectives on the different challenges raised when using the da Vinci system interface for performing surgery versus using conventional surgical procedures." The survey also could assess current and future trends in the robotic surgery. The survey results would be "qualitative in nature, not quantitative."
For now, the FDA is holding back on its view about the da Vinci – or even how physicians are using the robot until it gets more facts.
But the agency shouldn't wait too long, since many patient outcomes and huge dollars are hanging in the balance.
The issue of physician training is spotlighted in a case that is playing out in Washington state, where a jury will decide whether Intuitive Surgical, the maker of da Vinci, properly trained a physician who, in his first unassisted surgery using the company's da Vinci surgical system, removed the prostate gland of a patient who later died, according to Bloomberg News.