FDA Probes Docs Over da Vinci Robot Problems
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:
- How many surgeries and what types of surgeries have you performed using the da Vinci surgical system over the last three years?
- What procedures do you believe are most suited, or least suited for the da Vinci;
- Do you prefer the da Vinci system to conventional systems?
- What are the "problems or challenges" of the da Vinci?
- What "kind of complications" are you seeing?
- How is training usually conducted and how often does it occur?
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.
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