Summary:

Between 2007 and 2011, the number of surgical robots in U.S. hospitals increased from 800 to 1,400. A better reporting system could help doctors and patients better assess their safety.

da Vinci Si surgical robot
photo: Intuitive Surgical

Robots can make better surgeons than humans, especially when it comes to accessing hard-to-reach parts of the body and minimizing trauma. But like any machine, they can malfunction. A recent study by John Hopkins University researchers found that robot surgeons likely malfunction more than previously thought, raising questions about reporting systems.

“We need innovation in medicine and, in this country, we are tremendously good at introducing new technologies,” associate professor of surgery Martin Makary said in a release. “But we have to evaluate new technology properly so we don’t over-adopt — or under-adopt — important advances that could benefit patients.”

Surgical robots can perform a wide range of jobs, such as holding a rib cage apart, delivering radiation to a tumor or replacing a heart valve. The study looked at the roughly 1 million robotic surgeries that took place between 2000 and late 2012 and found that 245 complications occurred, resulting in 71 deaths. Excessive bleeding was the most common cause of death.

The researchers checked the deaths against court and media records and found that five deaths were never filed with the FDA. Two were filed once a story appeared in the media. Another study found that almost 57 percent of surgeons have encountered a situation where a robot malfunctioned and they had to switch to an alternate means of surgery.

Hospitals must report malfunctions and complications to the robot manufacturer which then must report them to the FDA. Considering that 1 million surgeries have occurred, the researchers believe there are many more deaths and complications that go unreported. Makary suggested moving to a system of standardized reporting and reassessing what types of complications are attributed to robots versus surgeons.

Either way, it’s likely the number of robotic surgeons in U.S. hospitals will continue to grow. Between 2007 and 2011, the number of robotic surgeries quadrupled. The number of surgical robots installed also increased from 800 to 1,400.

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