Many hospitals and healthcare facilities laud new state-of-the-art robotic surgeries which has gained a great deal of popularity in the last several years, performed for both the most routine procedures and very complex surgeries. Since human error may occur on the operating table, leading to adverse complications, and sometimes even death, experts are saying robotic surgeries are not free of issues either, and a federal agency is currently examining failures linked to surgical devices.
In light of this issue television network CNBC, has launched a four-part series on the complications, including deaths that have resulted in several lawsuits against Intuitive Surgical, the maker of the da Vinci surgical robot.
As robotic surgeries have gained momentum with the million-dollar, multi-armed da Vinci machine that was used in nearly 400,000 surgeries nationwide last year — many doctors and clinicians insist the robotic surgery is safe when performed by a properly trained physicians. However, there are others who argue that there simply isn’t enough research to be confident that robotic surgery is as good as, or as safe as, conventional surgery.
Advocates say robotically assisted surgery lets doctors control the robot during the surgery at a computer screen, which allow it to be more precise, proponents of the technology say patients can experience less bleeding and are even discharged from the hospital sooner. Despite the accolades da Vinci has received, the Food and Drug Administration is taking a closer look at reported issues connected to the robotic system.
Twenty-four year old Kimberly McCalla, for example, was to undergo a routine hysterectomy but died two weeks after the surgery. In a lawsuit filed by her father, Gilmore McCalla, the action alleges that the death of his daughter was caused not only by the surgeon’s mistakes during the procedure, but major flaws in the robot’s design. The lawsuit claims the da Vinci allegedly burned one of Kimberly’s arteries and her intestines. The lawsuit also alleges Intuitive Surgical did not give hospital staff adequate training on the robot’s use.
McCalla suffered bleeding into her pelvis from a laceration to a main artery during a robotic-assisted hysterectomy, her father claims. Her father also claims she died "as the result of, among other things, injuries sustained by the use of the da Vinci surgical robot.”
“The complaint says this doctor didn’t have the knowledge to properly control the machinery,” said New York attorney Paul Rheingold, who is representing McCall’s father.
"Blood was flowing from her leg, from between her legs," her father, Gilmore McCalla, told CNBC. "And two nurses were there around her, catching the blood with a bottle."
Intuitive Surgical, which makes da Vinci, declined to discuss their cases with CNBC because of pending litigation. Da Vinci is Intuitive Surgical’s only product, and it is the only robotic technology that is cleared for soft tissue surgery by the FDA. There are others – but those medical devices are approved for neurosurgery and orthopedics. The company argues against the notion that there’s been a jump in problems and insists the rise simply reflects a change it made last year in the way it reports problems and issues relating to surgeries.
Has the reports of deaths and subsequent probes hurt Intuitive Surgical? According to the article on cnbc.com, first quarter revenue, reported after Thursday's market close, beat on the top and bottom lines, but there was a hitch: Procedure growth of 18 percent trailed analyst expectations of around 21 percent.
"We are pleased with our first quarter revenue and earnings growth. Despite a concerted effort by vocal critics of robotic surgery, support remains strong among patients, surgeons and hospitals," said Gary Guthart , CEO of Intuitive Surgical. "Da Vinci Surgery has clinically proven benefits in offering a minimally invasive option to a broader group of patients than traditional technologies."
Edited by
Ashley Caputo
