The FDA looks into the safety of the da Vinci system in light of increased adverse incidents.
Surgical robots allow surgeons to perform a variety of less invasive operations because their miniaturized instruments can work through small incisions in the body and are more dexterous than traditional laparoscopic tools (see “The Slow Rise of the Robot Surgeon”). The result is that patients leave the operating room with a smaller surgical wound with the promise of faster recovery and less scarring.
In 2000, Intuitive Surgical’s da Vinci system became the first FDA-approved commercially available robotic surgical platform and has since been used on hundreds of thousands of patients. According to a report on Bloomberg’s news site, the FDA is now taking another look at the system in response to an increase in reports of adverse incidents. As reported by Bloomberg:
What the agency is trying to determine is whether a rise seen in incident reports sent to the agency are “a true reflection of problems” with the robots, or the result of other issues, said Synim Rivers, an [FDA] spokeswoman, in an e-mail. “It is difficult to know why the reports have increased,” she said.