Robots being used in surgery have been linked to 144 deaths in the U.S., according to a new report. Robots are used most commonly in gynecology and urology, and less often in complex surgeries such as cardiothoracic surgery, involving the heart, lungs or esophagus. The surgeries involve using very small tools attached to a robotic arm, which the surgeon controls using a computer.
Hundreds more injuries were caused by variety of robot malfunctions between 2000 and 2013, the researchers said.
The malfunctions included the equipment “sparking” during procedures – causing patients to be burned. There were also cases of bits of broken equipment falling into patients’ bodies. Other injuries were caused by “uncontrolled movements” by the robots and “system errors.”
The team of researchers examined 10,624 reports in a database of the U.S. Food and Drug Administration, which has only recently made the reporting of malfunctions mandatory.
“Sparking” led to 193 patients being burned between 2000 and 2013. Broken or burned pieces of equipment fell into the bodies of patients in more than 100 cases. “Uncontrolled movement” injured 52 people and killed two, while “system errors” were reported in around 800 cases. Device and instrument malfunctions have affected thousands of patients and surgical teams by causing complications and prolonged procedure times.
In total, deaths were reported in 1.4% of the filed reports on mechanical surgery, and injuries were reported in 13.1%. The researchers from the University of Illinois, MIT and Rush University Medical Center pointed out that as filing a malfunction report was only made mandatory in recent years, the numbers almost certainly underestimate the true death and injury count. More than 1.7 million patients underwent robotic surgery in the U.S. between 2007 and 2013. But “no comprehensive study of the safety and reliability of surgical robots has been performed”, the researchers said.
The number of deaths doesn’t include a comparison with surgeries carried out without robots, but the report reveals that the number of incidents has not fallen with time. The team claimed that his indicates that not enough is being done to prevent more of these incidents from happening.
“Device and instrument malfunctions have affected thousands of patients and surgical teams by causing complications and prolonged procedure times,” the team wrote in the report. “Understanding the causes and patient impacts of surgical adverse events will help improve systems and operational practices to avoid incidents in the future.”