At least 144 deaths have been linked to robotic surgery, according to the findings of new research that examines the rate of complications associated with surgical robots and instruments used during the minimally invasive surgery.
In a study published by the Cornell University Library on July 13, researchers from the Rush University Medical center in Chicago looked at adverse events collected by the FDA between 2000 to 2013.
The findings suggest that robotic surgery may carry a higher risk of problems when used for head, neck and cardiothoracic surgery, with a death rate 10 times higher than more traditional surgical methods.
Virtually all of the reports examined would have involved use of the da Vinci robotic surgical system, which was the only approved robotic surgeon during that time. The complex device features four arms that are remotely controlled by a surgeon through the use of hand and foot controls while sitting at a console that provides a virtual reality representation of the patient’s internal organs.
Over the past decade, robotic surgery has rapidly grown in popularity for a variety of different gynecologic, urologic and other laparoscopic surgical procedures. However, several studies have raised questions about the cost and effectiveness of the surgical system and the risk of robotic surgery complications.
Researchers looked at data submitted to the FDA’s Manufacturer and User Facility Device Experience (MAUDE), where every medical device manufacturer is required to submit reports involving problems linked to their devices. The study identified 10,000 adverse event reports linked to robotic surgery, 1,500 of which led to significant patient impact or injury.
On average, researchers found that about 550 adverse events occurred for every 100,000 robotically-assisted surgeries. The reports also linked robotic surgery to 144 deaths from 2000 to 2013.
The most common cause of robot surgery complications appeared to involve broken instruments, a malfunction that has risen sharply in recent years, according to the study. The next most common cause of malfunction was fallen pieces. followed by arcing or broken tip covers, system errors, and video/imaging problems.
“Device malfunctions impacted patients in terms of injuries or procedure interruptions,” the researchers determined. “In 1,104 (10.4%) of the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to reschedule it to a later time (2.5%). Adoption of advance techniques in design and operation of robotic surgical systems may reduce these preventable incidents in the future.”
While robotic surgery is promoted as a superior surgical technique, providing shorter recovery times and reduced scarring, many questions have been raised about whether the more expensive procedures provide sufficient benefits for many different types of surgery.
A study published in the October 2014 issue of Obstetrics & Gynecology indicated that robotic surgery complication rates could be as much as twice as high in procedures where an ovarian cyst or one or both ovaries were removed with the da Vinci surgical robot, when compared with traditional procedures.
In February 2013, a study published in the Journal of the American Medical Association (JAMA) found that da Vinci hysterectomies increase costs by more than $2,000, while providing virtually the same complication rate as laparoscopic surgery.
The device has also been subject to several recalls, usually involving attachments for the robotic arms, which have been linked to burns, tears, and other patient injuries.
Intuitive Surgical has faced many da Vinci robot lawsuits in recent years, alleging that the manufacturer of the surgical system failed to ensure surgeons were adequately trained and that inadequate warnings were provided about the risk of certain complications. Most of those cases have been settled.