Between 2000 and 2013, robotic equipment played a role in 144 surgery-related deaths in the United States, according to an analysis of records kept by the Food and Drug Administration (FDA).
The findings were first presented at the annual meeting of the The Society of Thoracic Surgeons as a retrospective on the state of robotic surgery.
First approved by the FDA in 2000, the use of robots in surgery has risen dramatically in the past decade, with 1.7 million procedures completed between 2007 and 2013. For example, robotic systems took part in only 0.5 percent of hysterectomies—removal of the uterus—in 2007; that figure jumped to 9.5 percent in 2010.
Gynecology and urology accounted for the vast majority of robotic procedures at 86 percent. The remaining 14 percent occurred in four other major surgical specialties: general, colorectal, cardiothoracic, and head and neck surgery.
The study looked at all the reported adverse events related to robotic surgical systems collected by the FDA, numbering 10,624 in total. The 144 deaths, therefore, account for 1.4 percent of problem situations.
Of those deaths, 60 percent were attributed to machine error, 33 percent to the inherent risks of surgery, and 7 percent to human error.
The specific death-inducing malfunctions were not described in the FDA data, but the breakdown of more than 8,000 different machine errors gives us a glimpse of what they might be.
The most common specific errors were “broken pieces falling” into the patient (15 percent), followed by burns, tears, and electric overheating (10 percent) and random movements (10 percent). Around half of the errors fell into the “other category,” which includes pedestrian problems like power outages.
Robots are normally deployed in laparoscopic surgeries, where a small incision is made at a distance from the targeted organ, and the surgeons operate with remote visual data provided by an inserted camera, called an endoscope. This method, also known as minimally invasive surgery, boasts less blood loss and shorter recovery time than open surgeries that often require wide cuts across the abdomen.
Traditional laparoscopic operations present a technical challenge for the surgeon: they have to handle lengthy tools, which require great precision and they lose the flexibility of adjusting tools with their wrists. Also the video feed can often be confusing since moving left is shown as moving right on the screen.
Automated instruments provide a number of advantages in laparoscopic surgeries: the robotic arm can be more intuitively operated because it can be adjusted to move in the same direction as shown on the endoscope monitor; the endoscope is more stable; and robotic systems can often provide more accurate imagery.
The report did not make a comparison of the risk involved in robotic surgeries with that of traditional laparoscopic or open surgeries, but previous studies have found that robotic surgeries were no safer than conventional laparoscopic operations.
A 2013 study of more than a quarter million hysterectomy patients found that while robotic surgery offered a shorter recovery time for patients—only 20 percent stayed in the hospital for more than two days, as opposed to 25 percent for those who had a traditional laparoscopic removal—the complication rate was the same 5 percent.
Robotic surgeries did cost significantly more than traditional laparoscopic surgeries, averaging $8,868 to the latter’s $6,651. Purchasing a single Da Vinci surgical system can add up to more than $2 million after add-ons.
Intuitive Surgical Inc., the company that makes the da Vinci Xi surgical system used by most hospitals, told the Wall Street Journal that it doesn’t matter if robotic systems don’t make a marked improvement in safety because they are easier to use, thus allowing more women to get hysterectomies.
Another 2013 study of more than 2,000 hysterectomy patients found that those who had a robot-assisted operation had a lower chance of readmission (1 percent) than patients who had undergone traditional laparoscopic operation (2.5 percent), although the authors did not say whether that was enough to recuperate the heightened cost of robot-assisted surgery.