A da Vinci lawsuit claiming the system led to the death of a patient is set to go to trial April 15, according to Bloomberg News (3/26/13). In the same article, it was reported that defendant Intuitive’s attempt to have the lawsuit thrown out was denied.
The robot lawsuit was filed by the family of Fred Taylor, the deceased plaintiff who underwent robotic surgery for a prostate procedure in 2008. The family maintains the surgeon who performed the procedure using the controversial da Vinci robotic system was insufficiently trained, and elected to perform the procedure without supervision too soon.
Robotic surgical procedures are performed with a doctor perched at a video game-style console several feet away from the patient. With the aid of a high-density display, the surgeon employs foot pedals and hand controls to maneuver mechanical arms equipped with surgical tools. A three-dimensional camera displays the procedure back to the surgeon.
While robots have been used in the manufacturing process for years, they are mostly based on computer protocols with highly defined and exact movements programmed into the computer, and duplicated with exact precision for each operation.
With the Da Vinci robotic surgical system, the surgeon is in control. He just isn’t using his hands.
Is it a better system?
According to defenders, the robotic system makes surgery less invasive, provides increased precision, eliminates tremors and provides magnified vision. “It’s basically laparoscopy on steroids,” said Dr. Gösta Iwasiuk, a Ventura, California general surgeon who has used da Vinci since 2004 in hundreds of procedures. In comments published in the Ventura County Star (3/4/13), Iwasiuk notes Community Memorial Hospital in Ventura has had no problems with the system, and blame for errors should be placed at the feet of the surgeon, not the equipment.
“It’s like any tool,” Iwasiuk told the Ventura County Star. “You have to use it right.”
That sentiment is echoed by spokespersons for Intuitive, who maintain that clinical evidence demonstrates the da Vinci system is safer than open surgery for procedures such as prostate removal and hysterectomies.
But there have been problems nonetheless. Whether the difficulties lay with da Vinci robot failure, or improper training and supervision of doctors as the Taylor da Vinci robot lawsuit alleges, there has been a sufficient increase in adverse incident reports to prompt the US Food and Drug Administration (FDA) to begin surveying surgeons about the system, and about the problems.
Adverse events include harm to the uterus and bowels, and occasions when surgical instruments placed into the “hands” of the robotic device have dislodged, and have fallen into the patient.
It should be noted that while the FDA has cited an undisclosed increase in adverse incidents related to da Vinci Robot injury, the manufacturer counters that the rate of adverse incident has not increased.
Fred Taylor, according to court documents cited in the Bloomberg report, suffered a one-inch tear in his rectum as a result of the robotic surgery. The patient also suffered kidney failure, brain damage and permanent incontinence, and later died of heart failure due, his family alleges, to his robotic surgery injury.
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According to Bloomberg, there are no fewer than 1,371 hospitals in the US employing the da Vinci system, even given the reported price tag of $1.5 million each.
The case is Estate of Fred E. Taylor v. Intuitive Surgical, 09-2-03136-5, Superior Court, State of Washington, Kitsap County (Port Orchard).