The adverse event reports sent to the FDA outline serious complications, including those involving gynecological surgeries that make up about half of the procedures involving Intuitive’s robotic system. They include damage to ureters and bowels as well as instances when instruments broke off from the robot and fell into patients. Reports also cited burns to various organs or vessels, most repaired during the surgery itself.
Many of the reports were filed by Intuitive Surgical and state that no robot malfunction was found or that the problem came from user error. Several originated from patients, who aren’t identified.
The robots are “extremely safe,” said Myriam Curet, Intuitive’s chief medical adviser, in a telephone interview. “There is a lot of redundancy in the system to make it as safe as possible.” The percentage of deaths and injuries involving the company’s da Vinci robotic system, “is extraordinarily small,” she added, and “hasn’t grown” over time.
While the number of adverse-event reports to the FDA is small compared with the total number of procedures, the agency’s reporting system has in the past served as an early warning system on concerns about medical-device safety.
“One of the risks is that the FDA could recall parts of the product or certain instruments, or somehow put restrictions on certain surgeries,” said Michael Matson, an analyst with Mizuho Securities USA in New York. “But I don’t think that’s very likely,”
A rise in adverse events isn’t necessarily alarming because the number of surgeries done with the robot has been growing rapidly, said Matson, who is based in New York and has a buy recommendation on Intuitive.
“The bigger concern would be that the patients would get scared,” he said. “Part of what’s driven this market is people seeking out robotic surgery; hospitals market it and the patients seem to think it’s better.”