Surgical Robot Injuries Are Allegedly Going Underreported to FDA

surgical robot injuriesWhile the number of robotic-assisted procedures is rapidly expanding, patients, regulators and hospitals may not be receiving enough information to determine whether these surgical systems and high tech approaches are worth the cost. According to one study, surgical robot injuries and complications, including death, resulting from using robotic equipment during surgeries have been reported inaccurately, late or not at all to the U.S. Food and Drug Administration (FDA).

If you or someone you love has suffered from surgical robot injuries and you would like to learn more about your legal rights, contact an experienced attorney today. You may be entitled to pursue a claim and seek compensation for your injuries.

Surgical Robot Injuries Underreported to FDA

The study, published in early 2013 in the Journal for Healthcare Quality, focused on incidents involving the da Vinci Robotic Surgical System, manufactured and marketed by Intuitive Surgical, for over 12 years. After combing through numerous databases to find troubled outcomes, researchers found 245 incidents that had been reported to the FDA including 174 nonfatal surgical robot injuries and 71 deaths. However, researchers also noticed eight cases in which reporting fell short, five of which did not involve an FDA report at all.

While this may seem trivial and unimportant, the assessment and approval process the FDA uses is based on reported device-related complications. If a device malfunctions, medical facilities are required to report the incident to the manufacturer, which then reports it to the FDA. The FDA then creates a report for its database. However, if facilities are not accurately reporting complications or failing to report them at all, the FDA has no knowledge of these complications and could incorrectly assume a medical device is safer than it is.

For its part, Intuitive Surgical maintains that the company may only report adverse events after it becomes aware of them. If hospitals are failing to report to the manufacturer, then the manufacturer does not have any indication that the device is causing complications. Intuitive also asserts that it takes the reporting requirement seriously and makes every effort to account for all events that could or will be reported, even those that happened several years prior.

Still, the study found that one patient’s injury and subsequent death occurred in 2009 but could not find record of the incident in the FDA’s database. Similarly, researchers found a report that came very late that matched the man’s case in 2010.

Risks of the Da Vinci Surgical System

Those who have allegedly experienced injuries following procedure using the da Vinci Surgical System claim that the device may cause:

  • Organ rupture
  • Severed ureters
  • Infections
  • Burns and tears to blood vessels, tissues, arteries and organs
  • Excessive bleeding
  • Bowel damage
  • Long-term disability
  • Death

Since it was first approved for laparoscopic procedures by the FDA in 2000, the use of surgical robots has rapidly grown. According to the study, between 2007 and 2011, the number of da Vinci Surgical Systems used across the country increased by 75 percent, from 800 to 1,400.

However, plaintiffs allege that the da Vinci Surgical System may cause serious injuries and that the robotic arm may uncontrollably jump around, inadvertently burning and injuring the patient. Other plaintiffs allege that Intuitive Surgical failed to properly train surgeons on the system although the manufacturer, for its part, maintains that it has not failed to properly teach healthcare facilities.

Suffering from Surgical Robot Injuries? We Can Help

If you or someone you love has been injured during a robot-assisted procedure and you feel that the da Vinci Surgical System is to blame, contact us today. At Attorney Group, we can answer your questions about the alleged surgical robot injuries or the lawsuits surrounding the da Vinci Surgical System. We will provide you with a free case evaluation and connect you with an experienced attorney who will handle your claim. Contact Attorney Group today for your free consultation.