Intuitive Surgical, the company that makes the da Vinci Robotic Surgery System, recently announced that it gained approval for a new robotic system, called the da Vinci Xi. Our team of da Vinci surgery injury lawyers takes a closer look at this new system and how it could affect patient care.
Robotic surgical systems are aggressively marketed to hospitals throughout the country as the “new, latest, most advanced” technology. In fact, there are no conclusive studies that show that such robotic systems provide better care for patients – quite the opposite. Hospitals are agreeing to pay millions of dollars (an average of $1.85 million) for these systems only to stay up on the competition.
The new Xi features thinner arms than the traditional da Vinci, and is intended to perform more complex surgeries. It also includes a fluorescent imaging system, nicknamed Firefly, which the company believes will improve patient safety by improving surgeon’s seeing ability. Other upgrades include new joints for greater range of motion and improved visual definition.
To use the robots, surgeons sit behind a console and operate the device using a control panel, which includes a screen, pedals and joysticks. The system has raised much controversy since its initial 2009 release, and several lawsuits have been filed against Intuitive by patients seriously, some fatally, injured by the robots.
Adding fuel to the fire, the FDA approved the Xi robotic system through a special process (called the 510(k) approval) that requires minimal testing. What makes this so disconcerting is that Intuitive has been reprimanded by federal authorities for withholding information on how many patients have actually been injured by the robots. All injuries and deaths associated with a certain type of medical device are reported by the hospital directly to the manufacturer. The manufacturer is then required to inform the FDA within 30 days of receiving the report, and is also required to investigate the injury or device malfunction, sending the FDA a report of this investigation once it is completed.
According to lawsuits against Intuitive, the company was systemically underreporting the complications caused by da Vinci robots, along with knowingly misclassifying serious injuries and deaths as “other.” The FDA was then never informed of the true injury risks from the da Vinci, and the public was never informed. The company also concealed three separate voluntary recalls from the FDA, which involved defective da Vinci parts. Due to their lack of reporting, dozens of patients were injured – specifically, burned – by malfunctioning parts.
According to reports, patients who are obese or who suffer from other serious
medication conditions are significantly more likely to suffer an adverse
event from the da Vinci. Other studies note that robotic surgery is not
at all superior to traditional methods.
The original system was approved for minimally-invasive laparoscopic surgeries on the gallbladder and for gynecologic procedures. It was later approved for more complex procedures, such as chest, cardiac, and urologic surgeries.
The actual stories from patients injured by da Vinci robots are gruesome and particularly devastating because they were completely preventable. Since the system is often used in gynecologic procedures, women throughout the country are now coming out with stories of perforated organs, burned tissue, and excruciating pain, to name only a few injuries. Several patients have died from accidental electrical burns and organ damage.
It is disappointing that the FDA chose to approve a new da Vinci surgical robot despite clear negligence by Intuitive – and through an expedited process, no less. Our team of da Vinci robotic surgery lawyers is here to help injured patients, even if the FDA is not. If you or someone you love was seriously injured in a surgical procedure using a robotic device, contact our firm immediately. We will investigate your case free of charge, and hold Intuitive responsible for its disregard. Our case reviews are always free, confidential, and available to injured patients nationwide.