Study: da Vinci Robot Incidents are ‘Vastly Underreported’

Problems with the da Vinci surgical robot have been “vastly underreported,” according to a study by Johns Hopkins University researchers.

Between January 2000 and August 2012, 174 injuries and 71 deaths – among thousands of mishaps – during da Vinci robot surgery were reported to the U.S. Food and Drug Administration, according to the study published in the September 2013 The Journal for Healthcare Quality.

Johns Hopkins researchers went through news reports and court records and tried to match them up against the da Vinci surgery injuries reported to the FDA. They found a lot more incidents than had been reported.

What gets reported to the FDA is only “the tip of the iceberg,” said Diana Zuckerman, president of the National Research Center for Women and Families. She was not involved with the study, but said underreporting skews the belief of what problems may actually exist with any particular medical device.

This is especially a problem with the da Vinci Surgical System because this surgical robot is so widely marketed in hospitals across the country, Zuckerman said.

One case that wasn’t initially reported to the FDA was a robotic endometriosis surgery assisted by a da Vinci surgical robot that lasted for almost 11 hours. That type of surgery typically takes less than two hours.

The Washington woman who was the patient in that 2009 da Vinci surgery had to be rushed to the emergency room because her colon and rectum were torn during the operation. As a result, she had to be hospitalized for another five weeks.

Medical device manufacturers and hospitals must report such cases to the FDA within 30 days of learning of the incident. But Intuitive Surgical Inc., maker of the da Vinci robot system, said the company did not know of the incident until being served with a lawsuit. The da Vinci robot lawsuit was settled in 2012.

Reports of problems with the da Vinci robotic arm – used in several common surgeries such as prostrate, gallbladder, cardiovascular and gynecological operations – have been on the increase.

Da Vinci robot lawsuits that have arisen out of various problems with the surgical robot have also accused Intuitive of aggressively marketing the robot and not giving surgeons proper training.

“This whole issue is symbolic of a larger problem in American healthcare, which is the lack of proper evaluation of what we do,” said Dr. Martin Makary, associate professor of surgery at John Hopkins and senior author of the study.

“We adopt expensive new technologies, but we don’t even know what we’re getting for our money — if it’s of good value or harmful.”

If you or someone you know was injured while undergoing surgery using a da Vinci robotic, legal options are available. Learn and get a free consultation regarding a claim’s eligibility at the Da Vinci Robot Surgery Class Action Lawsuit Investigation. Experienced legal professionals will contact you and guide you through the appropriate steps.