Intuitive Surgical, Inc., is the global market leader in robotic surgery, and it gained its market dominance when it released the U.S. Food and Drug Administration-approved da Vinci Surgical System into use in 2000. The da Vinci model is a computer-assisted device designed to facilitate surgery using a minimally invasive approach for general, urologic, gynecologic, thoracoscopic and thoracoscopically-assisted cardiotomy surgeries.
To date, an estimated 1.5 million da Vinci robot-assisted procedures have been completed, with the most commonly completed being laparoscopic hysterectomies and prostatectomies. As of September 2013, there were 2,042 da Vinci robots being utilized in hospitals across the United States, and more than 140 surgeons in Southwest Florida are deemed qualified to perform such procedures.
Despite the ongoing surge of support globally for the robot-assisted technology in operating rooms, the da Vinci Surgical System is picking up steady resistance from high-profile experts and researchers. Among the common complications observed with da Vinci procedures are perforations, lacerations, tears and electrical burns of surrounding organs. Also, some patients who were cleared to go home following seemingly successful procedures were checked back into hospitals days or weeks after their da Vinci surgery due to internal bleeding, infections, having robotic parts still inside of them and other serious injuries.
During the first 12 years of use of the product, an estimated 4,600 adverse event reports were posted in relation to the da Vinci product, which has been linked to more than 100 deaths. These numbers are on the climb, with the FDA receiving a massive increase of 3,697 reports posted in 2013 by Nov. 3. Bloomberg, a business and financial news source, recently published an investigative piece reviewing the failure of the da Vinci manufacturing company to adequately report device corrections and patient adverse events to the FDA, indicating that these statistics will only increase from here.
Lawsuits are being filed nationwide naming da Vinci Surgical System’s manufacturer and some of the doctors who have used the robots in surgery as defendants. 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.