Negative Event Reports Double for Surgery Robots

The robotic surgery industry, pioneered by Intuitive Surgical, has hit some rough spots over the past few years, with increasing numbers of patient injuries among its problems. According to federal regulators, the number of negative incident reports involving Intuitive’s da Vinci surgical robots more than doubled between 2012 and 2013, further revealing the inherent dangers of these machines.

Surgical robot attorneys at Pintas & Mullins Law Firm are keeping a watchful eye on Intuitive’s training, maintenance and remedial practices as more and more injury lawsuits are filed against the manufacturer. The recently-released physician survey, reported on by Bloomberg, found no consistent training programs for surgical robots despite the complexity of these devices.

FDA Survey Reveals Patient Complications, Doctor Misuse

Between January and November 2013, the FDA received nearly 3,700 adverse incident reports, which is more than double the number in 2012 (just over 1,500). This number does not reflect the true number of adverse events, however, because the FDA-reporting system is entirely voluntary and largely unverifiable.

Nonetheless, the FDA interviewed 11 physicians who used the robots to perform anywhere between 70 and 600 surgeries each. Among the technical complications reported were instances of missed incision marks, inadequate training, and robot arms colliding; complications that directly affected patient health and safety included finger nerve damage, peripheral vision loss, limb palsy, and bleeding from perforated bowels.

Doctors reported training experiences that varied significantly, and many were completely unaware of Intuitive’s surgical device recalls. One of the most recent recalls, initiated in July 2013, was in response to inadequate testing on several da Vinci devices. The second most recent, initiated in May 2013, affected the EndoWrist Instrument Hot Shears.

Additionally in July 2013, Intuitive received a federal warning letter regarding an inspection which found that adverse events were not properly being reported to the FDA, among other violations. The company’s marketing practices have also come under much scrutiny recently, as many believe the aggressive sales team fraudulently misrepresented to hospitals how the robotic systems can help them gain a “competitive edge.”

Liability Lawsuits Proliferate

To date, there have been over 50 liability lawsuits filed against Intuitive by patients who were seriously harmed by the surgical robots. Many doctors assert that injuries suffered by patients during robotic operations – where physicians sit at a video-game style monitor and control the arms with foot and hand controls – relate directly to the surgeon’s training experience.

Despite Intuitive’s aggressive marketing campaigns, there are no studies or trials signifying that robotic operations offer significant health benefits. The clinical trial conducted to clear the da Vinci for use by the FDA was done on just over 230 patients in Mexico City, for example, which was in 2000. There is no other randomized trial to prove its benefits.

Lawsuits over Intuitive’s da Vinci Surgical Systems have just begun going to trial. Our team of surgical robot lawyers will report on any significant verdicts and settlements as they arise. If you or a loved one was seriously injured by a da Vinci robot or any other surgical system, contact our firm today for a free legal evaluation.

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