When the FDA approved the da Vinci Surgical System in 2000, commissioner Jane E. Henney said the robotic arm could “eventually… change the practice of surgery,” according to ABC News. Unfortunately, it has—by adding to the number of surgical mistake lawsuits in this country.
The da Vinci robotic arm system is supposed to help surgeons “perform delicate and complex operations through a few tiny incisions with increased vision, precision, dexterity, and control,” per manufacturer Intuitive Surgical’s website. And, in fact, the FDA approved the device because it proved to be as safe and effective as standard laparoscopic surgery.
A decade later, the da Vinci robotic arm has developed a mind of its own, according to Medscape. Adverse event reports to the FDA have cited damaged organs and severed nerves. One stated that the arm refused to release a patient’s tissue.
“We had to do a total system shutdown to get the grasper to open its jaws,” that report stated.
WHAT CAUSES ROBOTIC ARM SURGERY MISTAKES?
The number of adverse event reports skyrocketed 34 percent between 2011 and 2012, but the company has blamed this on the fact that more surgeons are using the da Vinci robotic arm.
To that end, one doctor told CBS that his hospital performed a mere 175 robotic surgeries in 2008 but expected to do more than 1200 in 2013.
Another doctor blamed that increase on aggressive marketing.
“He led a study published in 2011 that found 4 in 10 U.S. hospitals promoted robotic surgery on their websites, often using wording provided by the manufacturer,” CBS News stated. “Some of the claims exaggerated the benefits or had misleading, unproven claims.”
In November 2013, the FDA decided to survey surgeons about da Vinci’s benefits and downsides.
“Surgeons were asked, among other things, about user training, common equipment repairs, patient selection, the complications they saw and how they compared with those seen in conventional surgeries, and what procedures are the best and least suited for the da Vinci technology,” per Medscape.
A month after its survey, the FDA announced a Class II recall of da Vinci systems and da Vinci EndoWrist needle drivers, justice.org reported. “[Intuitive Surgical] has reported 82 incidents related to damaged or detached needle driver jaw inserts, including 27 incidents where the inserts fell off during surgery. In one case, a device fragment was not retrieved during surgery after falling into the patient, so a second operation was required to remove it.”
DA VINCI ROBOT LAWSUITS
Not surprisingly, the company has faced numerous lawsuits. “Plaintiffs blame their injuries on alleged product defects and ill-trained surgeons,” Medscape reported.
One family was awarded $7.5 million after a surgeon using the robotic arm punctured a 49-year-old man’s intestines during spleen surgery.
“The injuries went undetected for about two weeks while [the patient] suffered an infection, brain damage, [and] organ failure before slipping into a coma and dying,” per an ABC News affiliate. The family’s lawyer told the jury that using the robotic arm for this type of surgery was unnecessary and akin to “using an 18-wheeler to go to the market to get a quart of milk.”