Surgical Robots Linked to 144 Patient Deaths

The innovations in robotic surgery are exciting as precision is being honed by surgeons, but a recent study about the adverse events in robotic surgery reminds the medical community of the risk when using these devices.

From 2000 to 2013, there were 144 deaths related to surgical robots, in addition to 1,391 patient injuries and 8,061 device malfunctions.

This data was collected from the U.S. Food and Drug Administration’s Manufacturer ad User Facility Device Experience (MAUDE) database, and the researchers’ results were published in the report Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data.

“Despite widespread adoption of robotic systems for minimally invasive surgery, a nonnegligible number of technical difficulties and complications are still being experienced during procedures,” the report concluded. “Adoption of advanced techniques in design and operation of robotic surgical systems may reduce these preventable incidents in the future.”

From 2007 to 2013, more than 1.74 million robotic procedures have been performed, which was a big increase over previous years. With the increase in use, study authors wrote, “An important question is whether the evolution of the robotic systems with new technologies and features over the years has improved the safety of robotic systems and their effectiveness across different surgical specialties.”

According to the data, there is still work to be done. Here are some findings:

The average number of adverse events, like injury or death, were about 550 very 100,000 procedures between 2004 and 2011.

Adverse event numbers peaked in 2013 with about 1,000 events every 100,000 procedures.

Cardiothoracic and head and neck surgery patients were more likely to die due to an adverse event than gynecology and urology patients. This is thought to be because of the complexity of the cases.

Device and instrument malfunctions were broken into five categories: system errors and video/imaging problems (787 events); falling of the broken-burnt piece into the patient’s body (1,557 events); electrical arcing, sparking or charring on instruments (1,111 events); and unintended operation of instruments (1,078 events). Device malfunction presents three options – restarting the system, converting to a non-robotic procedure or rescheduling the surgery.

“While the robotic surgical systems have been successfully adopted in many different specialties, this study demonstrates several important findings: (1) the overall numbers of injury and death events per procedure have stayed relatively constant over the years, (2) the probability of events in complex surgical specialties of cardiothoracic and head and neck surgery has been higher than other specialties, (3) device and instrument malfunctions have affected thousands of patients and surgical teams by causing complications and prolonged procedure times,” researchers reported. “As the surgical systems continue to evolve with new technologies, uniform standards for surgical team training, advanced human machine interfaces, improved accident investigation and reporting mechanisms, and safety-based design techniques should be developed to reduce incident rates in the future.”