May 6, 2013 – Last week, a product liability lawsuit was filed against Intuitive Surgical on behalf of 15 individuals who claim to have suffered serious injuries after undergoing procedures with the company’s da Vinci robot. The complaint alleges that the manufacturer sold a defective medical device and made false claims about its safety and effectiveness. The lawsuit is just the latest of a growing number of similar claims filed in courthouses around the county on behalf of individuals who allegedly suffered adverse health complications following robotic surgeries with the da Vivci system.
Da Vinci Robot Recall March 25, 2014: Intuitive Surgical has issued a nationwide recall for certain cannulae components used with the da Vinci Robot, due to the risk that the parts may be damaged during use and could be hard to replace. To date, at least one patient has experienced injuries that may have been caused by a damaged cannula, which occurred when the tube rotated and punctured the patient’s abdomen.
What’s the Problem?
The new da Vinci Robot Lawsuit was filed on April 29 in the U.S. District Court for the Eastern District of Louisiana on behalf of 15 of the state’s residents who allegedly suffered serious injuries after undergoing treatment with the device. According to the suit, the da Vinci surgical robot has been repeatedly linked to a number of complications including damage to the bowel, blood vessels, arteries, ureters, bladder, vaginal cuff, and other injuries.
In recent years, Intuitive has heavily marketed the da Vinci Robot as a less invasive surgical technique that requires substantially less recovery time than conventional methods. The robot features a control panel where a surgeon can see a virtual reality image of the patient’s internal organs, and manipulate the device’s four metal arms with hand and foot controls. However, despite initially being hailed as a revolutionary breakthrough in medical device technology, the da Vinci surgical robot has recently been linked to numerous reports of severe internal injuries and death, leading to a safety probe by the U.S. Food & Drug Administration (FDA).
Potential design defects named in the new complaint include the use of monopolar energy to cut, burn and cauterize tissue, as well as inadequate insulation for the arms of the device, which can allow electrical current to pass into patients’ tissues. The lawsuit also alleges that the manufacturer over-promoted the robot, while minimizing the risk of potential complications and failing to provide a sufficient amount of training for surgeons.
“Due to design defects, [da Vinci robots] have malfunctioned during the course of operative use causing injury, including the necessity of converting the procedure into open surgery, or often requiring subsequent surgeries to deal with complications of robotic use,” read the complaint. “[Intuitive Surgical] has failed to warn users and consumers of its device of the design flaws…, although it has reached directly to consumers to promote its asserted advantages.”
The new complaint came just days after a da Vinci Robot Class Action Lawsuit was filed by a number of investors, who claim that Intuitive provided misleading data about the device’s safety and effectiveness, and allege that information was intentionally withheld about reported problems and the mounting litigation that could negatively affect the company’s value.