da Vinci Robot Surgery – Latest Isn’t Always the Greatest

FDA Warns of an Increasing Number of Adverse Events Associated with da Vinci Robotic Surgery

George T. Williamson, Attorney
George is developing his practice in the areas of general civil, commercial and complex litigation as well as mass tort litigation.

Intuitive Surgical is the global market leader in robotic surgery. The company gained its market dominance by developing a robotic surgical system called the “da Vinci” which has been approved for use by the FDA since the year 2000. The da Vinci Surgical System is a computer-assisted device designed to facilitate surgery using a minimally invasive approach. The da Vinci robot is used in several medical specialties and for multiple purposes. Most commonly it is used by obstetricians and urologists in performing laparoscopic hysterectomies and prostatectomies, respectively.

As of September 2013, there were 2,042 da Vinci robots being used in hospitals across the United States. The robot has gained significant traction in these hospitals by promoting the manufacturer’s promise of a shorter hospital stay, fewer complications, and a faster recovery. Indeed, many hospitals in Southwest Florida have purchased the da Vinci from Intuitive Surgical at a price of between $1.5 million and $2.2 million (depending on the model) with an additional, required annual service contract of $150,000. It stands to reason that these hospitals are now aggressively marketing the device to doctors and patients alike to cover the cost of the robot.

However, as the da Vinci robot gains in popularity, the FDA warned that an increasing number of adverse events have been associated with the device, including perforations, lacerations, tears, and electrical burns of surrounding organs leading to thousands of patient injuries and well over 100 deaths. In the first 8 months of 2013 the FDA saw a massive increase in adverse events connected with the da Vinci Surgical System; 2,332 compared to 4,603 reports posted in the entire 12 year period since the first adverse event tracking for the da Vinci. In many cases the da Vinci surgery is considered successful and the patient is discharged, only to return to the hospital days or weeks later with internal bleeding, infection, robotic parts still inside of them, and other serious injuries.

In lawsuits filed against Intuitive Surgical, injured patients have alleged that the robot malfunctioned during surgery causing significant injuries and complications. The lawsuits further allege that Intuitive Surgical fraudulently overstated the devices capabilities and failed to properly train doctors on how to safely operate the device.

If you or someone you know has suffered severe complications as a result of a da Vinci robot assisted surgery, please contact our law firm for a free and confidential consultation.