Fred E. Taylor, 67, arrived at Harrison Medical Center in Silverdale, Wash., on Sept. 9, 2008, for what was supposed to be a routine surgical procedure: a prostatectomy. If the simplicity of the operation was not enough to ease any of Mr. Taylor’s concerns, he could always remember that his surgeon would be getting robotic assistance courtesy of the da Vinci Surgical System – a device that would make the operation safer, less painful and easier on the body than traditional surgery.
But on that day in early September, something went horribly wrong with Mr. Taylor’s surgery; it did not play out even remotely as planned.
The procedure, which was supposed to take about five hours, was plagued by a series of complications that caused the operation to persist for more than 13 hours.
The end result was that Mr. Taylor, formerly an active retiree, was rendered incontinent and required to wear a colostomy bag. The surgery also caused damage to his kidneys and lungs. He was overcome by sepsis, a severe blood infection, and then a stroke.
Complications from the surgery had restricted his ability to live life to the extent that he would weep, telling his wife, Josette, that he felt like he was “trapped in this body,” Josette said.
Taylor survived his da Vinci surgical experience for many years, but finally succumbed to his health problems and died last year.
The task of balancing the scales was left to Josette, who has filed a lawsuit against Intuitive Surgical. A key charge is that the operation had been performed by a surgeon who was using the da Vinci system alone for the first time.
Intuitive Surgical is facing an accretion of lawsuits specifically charging it with failing to provide sufficient training for the doctors who use its robotic systems.
The da Vinci surgical robot was approved by the U.S. Food and Drug Administration (FDA) in 2000. The ability to perform less invasive surgery coupled with a swifter recovery period for the patient are key benefits touted of the da Vinci surgical robot. Additionally, it has been used in a growing range of procedures, including kidney cancer and other kidney disorders, prostate removal, throat cancer, coronary artery disease, heavy uterine bleeding and obesity surgery, according to the marketing materials.
But as the uses for the device continue to grow, so do the reports of injuries and complications experienced during and after those surgeries. Some of the more serious injuries associated with use of the device range from tears and burns to perforations to arteries and organs. In some cases, such as that of Fred Taylor, the end result is death. Still, hospitals are increasingly using the da Vinci surgical robot to perform a wide and growing range of surgeries.
According to Intuitive, 1,371 hospitals in the United States have purchased a da Vinci system, with many facilities purchasing two. These surgical robots were used in 367,000 operations in the United States last year – and the devices are linked to 70 deaths, according to “informal incident reports” sent to U.S. regulators since 2009, Bloomberg News has reported.