The Food and Drug Administration keeps meticulous records concerning instances of medical devices, including robots, malfunctioning or acting in ways that they aren’t supposed to.
Those records are stored in the Manufacturer and User Facility Device Experience (MAUDE) database, and a team of researchers from MIT, the University of Illinois at Urbana-Champaign, and Rush University Medical Center have been digging through them to understand how medical robots have affected the field of medicine.
What they found was…distressing, to say the least.
From 2000 (when the da Vinci Surgical System was first approved by the FDA) to 2013, there have been 114 deaths directly linked to robot-assisted surgeries. The research team also found that in addition to a consistent (but low) death rate, medical robots were sometimes observed breaking or occasionally leaving pieces of themselves inside of patients.
Also, there were: 193 reports of people being burned by sparks emitted by robots during surgery; 100 documented cases of robot pieces falling off and into people, 52 instances where robot arms straight up went haywire inside of people, seriously injuring them.
These figures number pale in comparison to the estimated 210,000-440,000 people who die from medical mistakes annually, and the thousands more that suffer from human error every year. Doctors and nurses leave medical equipment inside their patients, too. Still though, the study chips away at the idea that robotics make invasive surgery uniformly “better” than more traditional methods.
All things considered, instances of death and harm were fairly low, but it’s important to point out that they were consistent across 13 years. That consistency would appear to indicate that whatever technical malfunctions are causing robots to hurt people aren’t really being worked out. The possible solution? Paying more attention, say the study’s researchers.
“Adoption of advanced techniques in design and operation of robotic surgical systems may reduce these preventable incidents in the future,” they insist.