Robot-Assisted Surgery Linked to 10,000 Injuries, Malfunctions, and Deaths, FDA Reports

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Robots have been used in surgical procedures with increasing frequency since the year 2000, providing surgeons a way to work remotely and precisely on patients without “opening them up.” Since that time, however, these robots have been involved in a number of patient injuries and deaths, according to a U.S. Food and Drug Administration (FDA) report involving over 10,000 incidents.

The data was collected from the Manufacturer and User Facility Device Experience (MAUDE), a database where physicians, patients, and manufacturers report adverse events suspected to be caused by medical devices. In total, surgical robots were reported as being involved in 144 deaths, 1,391 injuries, and 8,061 device malfunctions that either extended the surgery or forced it to be switched to a non-robotic procedure. Due to changes in reporting practices and the fact that doctors, patients, and users may underreport (it is only mandatory for manufacturers), these numbers are considered low-end estimations.

Among the deaths reported, about 33% were attributed to inherent surgical risks and complications, seven percent to operator error, and 62% to device malfunctions. These malfunctions consisted of burnt or broken fragments of tools falling into the patient, electrical sparking or arcs, and the robot making an unexpected movement. Similar rates were found for patient injuries in robotic procedures.

Since 2007, the annual rate of these injuries and deaths has been relatively constant. Among specialties, gynecology and urology procedures have the lowest rate of injury or death from robotic procedures, and cardiothoracic or neck operations have the highest.

The report recommends surgical robots be improved with better feedback and modeling so the robot’s motions can be better observed and adjusted. Better training and simulation for surgeons will help improve the human-machine interaction and make them more familiar with how to adapt to problems that arise during real operations.

Although there is clear room for improvement, robot-assisted surgeries have remained a useful, largely safe, and important tool in the surgeon’s arsenal. For a sense of context, during the 14-year period covered by the study, twice as many patients were caught on fire during surgery than were injured or killed by robots.

Sources for Today’s Article:
Alemzadeh, H., et al., “Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data,” at the 50th Annual Meeting of the Society of Thoracic Surgeons in January 2013, Arxiv.org; http://arxiv.org/ftp/arxiv/papers/1507/1507.03518.pdf, last accessed July 22, 2015.
“Surgical Fire Prevention,” ECRI.org; https://www.ecri.org/Accident_Investigation/Pages/Surgical-Fire-Prevention.aspx, last accessed July 22. 2015.




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Adrian has been working in the information publishing world since 1997. But when it comes to health information, he’s a self-admitted late bloomer. A couch potato since pre-school, Adrian was raised on TV, video games and a lifestyle that led to childhood obesity that followed him well into adulthood. But when he hit his forties, he decided enough was enough. He had a family to take care of and his days of overeating, under-exercising and inactivity were going to lead... Read Full Bio »