According to several national news sources, research shows that the da Vinci Surgical System might be a dangerous device due to its design and/or insufficient operator training. Intuitive Surgical maintains that the da Vinci Surgical System is not problematic.
Lawsuits Over Injuries Caused by da Vinci Robots Are Pending
In March 2012, a jury in Illinois awarded a decedent’s family $7.5 million upon determining that the man’s surgeon’s negligence caused the man to die on the operating table. It was the surgeon’s first time using a da Vinci robot on a living patient. There are at least five other da Vinci lawsuits currently pending.
What Is the da Vinci Surgical System?
Believing that many procedures could be performed more efficiently if the surgeon could be replaced with a robot, Intuitive Surgical designed the da Vinci Surgical System, a four-armed robotic device operated by human surgeons sitting 20 feet away from the operating table before a terminal, joysticks, and foot pedals. The da Vinci’s supporters claim that the device allows surgeons to perform complex procedures in ways they otherwise could not. They also believe that robotic surgery can reduce subsequent complications and recovery times.
According to the Seattle Times, a da Vinci system costs hospitals $2.6 million, and critics claim robotic surgery does not contribute to improved outcomes and is the result of a “medical arms race” among hospitals competing for market share by using untested technology. In an article published in January 2012 in the Journal of Clinical Oncology, researchers determined that a robotic hysterectomy to treat endometrial cancer cost patients an additional $1,300 on average over traditional laparoscopic hysterectomies with no additional benefit to them.
The da Vinci Surgical System Might Cause Serious Side Effects
One concern with the Da Vinci Surgical System, the Seattle Times noted, is that there are no national standardized tests to ensure proficiency by the surgeons who operate the devices. Intuitive Surgical runs a three- to four-day course for surgeons at its headquarters, training them on cadavers. Whether they are allowed to operate on living patients is up to their hospitals, leading to inconsistent requirements and, sometimes, tragedies. Intuitive Surgical asserts that it is fully committed to superior training opportunities for surgeons and surgical teams in the use of its products, but notes that it does not participate in determining when a surgeon is adequately prepared to operate using the da Vinci Surgical System.
Some patients who have undergone da Vinci robot surgery discovered that the machine caused them side effects that would not have occurred with traditional surgery, such as:
- internal lacerations to organs
- internal burns to organs and blood vessels
- excessive bleeding
- nerve injuries
According to a paper published in the Journal of Urology and reported by Reuters, between six and seven percent of patients who underwent a surgery involving a robot reported suffering from positioning injuries caused by their bodies’ orientation during the procedures. Patients’ bodies are often tilted downward at a steep angle, which pulls on the muscles and nerves depending on how patients are suspended in place. The resulting weakness or numbness can last at least a month, but some patients reported six months or more of numbness. Injuries were associated with the duration of the procedures.
On March 1, 2013, Bloomberg reported that the U.S. Food and Drug Administration (FDA) surveyed surgeons, asking them to list the complications patients had encountered after undergoing operations performed with the da Vinci. The FDA also asked which procedures the machines were best suited for and what training the surgeons had received prior to using the da Vinci. Bloomberg linked the da Vinci to 70 deaths between 2009 and 2013.
Intuitive Surgical, however, maintains that there is a “clear and growing consensus in the peer-reviewed literature that the da Vinci Surgical System has been shown to be a substantially safer option than open surgery across a multiplicity of surgeries.”
In July 2013, Intuitive Surgical acknowledged that it had received a warning letter from the FDA regarding inadequate reporting of device corrections and adverse events. By October 2013, the agency had received more than 4,000 adverse event reports, and in November Intuitive Surgical notified customers that the robot could stall during surgery. At least one of Intuitive Surgical’s insurers has attempted to cancel its coverage because it believed the company inadequately reported adverse event reports.
Intuitive Surgical Issued Urgent Safety Warning re: Robots’ Scissors
In May 2013, Intuitive Surgical, the manufacturer of the daVinci, issued an “urgent medical device notification” alerting hospitals that it has “identified a potential issue” with one of the robot’s instruments that can cause internal burns. According to the notification, some of the robot’s curved scissors contain “micro-cracks” that may not be visible to the naked eye and that “may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause thermal injury.”
The notification specified, however, that Intuitive Surgical, had not “confirmed evidence of patient injury attributable to this issue.”
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a da Vinci Surgical System lawsuit on your behalf if necessary.
If your surgeon used a da Vinci Surgical System during your procedure and you believe it harmed you, contact RLG today.