The United States Food and Drug Administration (FDA) has recently revealed that robotic surgeons have been involved in the unfortunate deaths of 144 patients over the course of 14 years. The data examined started being collected in the year 2000 and the process lasted all throughout 2013.
What’s more, the paper also revealed that certain types of robotic surgery pose much more of a threat than others. For instance cardiothoracic surgery, head and neck surgery proved to be the most dangerous as the death rate of patients who underwent these types of surgeries was roughly 10 times higher than that of patients who underwent a different type of surgery.
The news si alarming as robotic surgery has been gaining popularity points in recent years. In the US alone over 1.7 million robotic surgeries were performed between the years of 2007 and 2013. Most of these procedures were performed in urology and gynecology.
Jai Raman, study leader and member of the Medical Center from Rush University (Chicago), and the rest of the researchers stressed that despite this increase in popularity, no one thought to conduct a comprehensive study investigating the safety and reliability of robotic surgeries.
To fix this, they looked at some of the Food and Drug Administration’s records and analyzed the recorded incidents where a robotic procedure was not able to save a patient. It’s mandatory for all such incidents to be reported and documented in the Manufacturer and User Facility Device Experience (MAUDE) database.
Raman and his team examined more than 10.000 reports which referred to robotic procedures. More than 1.500 of them mentioned that the impact these experiences had on patients was significantly negative. This translates to a ratio of roughly 550 adverse events for every 100.000 procedures that took place.
Since 2006, the number of deaths and injuries linked to robotic surgeries has become 30 times bigger than it used to be. The number of injuries per surgery, on the other hand, has remained mostly the same since 2007.
The danger can be found in five (5) big categories, the three (3) main ones being the possibility of the equipment sparking or arcing during a surgery (a malfunction that burned 193 people between the years of 2000 and 2013), the possibility of burned and / or broken pieces falling onto a patient’s body (more than 100 people experienced this malfunction and one of them was killed by it), the possibility of the instruments exhibiting uncontrolled movements (a malfunction that cause 52 injuries and 2 deaths).
However, system errors were revealed to be the most common reason for unwanted outcomes. Loss of video feed was responsible for roughly 800 adverse events.
Of the 144 reported deaths, more than 60 percent (60%) of them were a direct result of system malfunctions. The other 40 percent (40%) were a result of either operator errors or the inherent risks of a certain surgery.
It’s important to note that most robotic surgeries aren’t plagued with any unwanted incidents and that Raman and his team did not compare these results to the number of injuries and deaths from surgeries without robotic techniques.
Image Source: biomed.brown.edu