da Vinci Robotic Surgery Injury Cases Often Not Reported to FDA: Report

A recent investigation by Bloomberg News suggests that doctors and hospitals may be underreporting complications following da Vinci robotic surgery, highlighting what some critics say is wrong with the FDA’s voluntary adverse event reporting system.

Although there were at least 3,697 adverse event reports involving da Vinci surgery received by the FDA through the first 10 months of 2013, this likely represents only a miniscule fraction of the true number of issues experienced by patients and many of those reports were only filed after da Vinci surgery injury lawsuits were filed against the manufacturer of the robot, observers say.

According to the Bloomberg News report, many doctors and hospitals are not reporting problems as they should. A review of adverse event reports involving the da Vinci robot found that many cases cited in lawsuits and patient interviews were never reported by the hospital or surgeon, and many of the ones that were eventually reported were not submitted to the FDA until years after the injury was experienced.

In September 2013, researchers from Johns Hopkins also suggested that there has likely been chronic underreporting of robotic surgery complications. In a report published in the Journal for Healthcare Quality, researchers suggested that the underreporting of da Vinci robot complications was likely making the da Vinci robot look safer than it really is for patients. The researchers were suspicious of the low numbers of adverse events reported in connection to the robot and went out and found numerous incidents where problems were not reported to the FDA until after they had been exposed by main stream media news reporting.

da Vinci Robot Complications

Over the past year, as the popularity of robotic surgery involving the da Vinci Surgical System has increased at hospitals throughout the United States, concerns have also emerged about risks associated with the procedures and whether Intuitive Surgical may have withheld information about potential issues with the da Vinci robot and provided inadequate training and instructions for surgeons.

The da Vinci robot contains four metal arms that are remotely controlled by the surgeon during robotic procedures, using hand and foot controls while looking at a virtual reality representation of the patient’s internal organs. After hospitals spend millions acquiring the expensive robotic surgery machine, concerns have been raised about whether patients may be pushed toward the new procedures, despite questions about the added benefits provided.

While da Vinci surgery has been promoted as a superior and less invasive procedure, questions have been raised about the risk of da Vinci robotic surgery complications that have surfaced when individuals suffered burns, tears and other injuries from electrical arcing.

The Bloomberg News report came shortly before a study published in the January issue of Obstetrics and Gynecology, which suggests that use the da Vinci robot to perform surgery to treat pelvic organ prolapse (POP) on women is substantially more expensive than performing the same procedure through laparoscopic surgery. However, the rate of complications and short-term outcomes between the two procedures were similar.

Sacrocolpopexy surgery, as the procedure is known, has an initial cost of $11,573 when it is performed via laparoscopic surgery. But when it is conducted via robotic surgery, which supposedly reduces scarring and recovery time, the cost jumps to $19,616 on average, according to the study’s findings. Patients undergoing robotic surgery appeared to be in more pain a week after surgery. It also took longer to operate with the da Vinci robot. There were also no differences in the rate of surgical complications and adverse events reported.

The FDA adverse event reporting system relies on doctors, hospitals and manufacturers to voluntarily problems and complications associated with medical devices. However, the apparent underreporting of da Vinci injuries seems to highlight the potentially conflicting interests in this system.

Many of the reports actually submitted by Intuitive Surgical, the manufacturer of the da Vinci robot, contain vague information that appears to downplay the role of the medical device in the complications experienced by patients.

In October, Citron Research, an investment analysis firm, issued a report warning investors that the stock price for Intuitive Surgical was precarious. Citron noted that da Vinci robot surgery complaints surged this year, and found that all of the complaints filed by Intuitive Surgical appeared to have addendums that suggested the manufacturer was attempting to dodge any and all responsibility for da Vinci surgical injuries.

Some of the reports were filed years after the injury happened, and while Intuitive Surgical officials told Bloomberg News it reported in a timely manner, the FDA hit the company with a warning letter this summer after it found that the company was failing to report da Vinci robot problems to the agency.