The medical device manufacturer Intuitive Surgical, Inc. continues to run into legal trouble over their Da Vinci Surgical Robot. An increasing number of injuries connected to this device and questions over Intuitive’s training and credentialing processes have made this product the source of numerous lawsuits.
Intuitive’s surgical robot was cleared by the FDA in 2000 and claims to be a much-desired minimally invasive alternative to traditional surgery. The robot functions similar to a video game; the physician sits several feet away from the patient and uses a small screen and hand and foot pedals to control the robotic arms. According to the Los Angeles Times, use of the Da Vinci robotic surgery “…has quadrupled in the last four years, and the machine now helps with incisions and sutures in 2,000 hospitals around the world.”
Although this medical device has been touted as a great innovation superior to traditional surgery, its risks may outweigh the benefits. Common complications associated with the Da Vinci robot include extreme internal burning in areas surrounding the incision site. Additionally, Reuters reports that nerve damage has increasingly become a problem in these robotic surgeries due to the way the device requires a patient to be placed on the operating table. These “positioning injuries” occur because the patient must lie on a large ramp, with their head closest to the ground, to allow the doctor greater traction. However, sliding can easily occur and the patient can experience pulling on their nerves. Reuters reports a study in which of 334 patients who underwent Intuitive’s robotic surgery, 22 woke up with nerve injuries related to their positioning.
In addition to the danger of severe complications, Bloomberg has recently noted that some of Intuitive’s business operations may also be questionable. According to recent lawsuits, Intuitive has insufficient training regimens available to those who will operate the device. The major problem with Intuitive’s training regimen is the lack of requirement for doctors to practice under the guidance of a physician who is experienced with the surgical robot. In fact, in the attempt to sell his product, one Intuitive salesman reportedly told a hospital that five supervised surgeries is too many, that a doctor may be considered credentialed to use the robot with even less supervision. This salesman’s manager praised him for using this tactic.
According to the San Francisco Chronicle, the FDA recognizes that the alleged problems with the Da Vinci Surgical Robot have led to over 4,600 injuries and at least 80 deaths. Don’t let a defective medical device ruin your life. Profit-driven medical device manufacturers may often mislead the physicians and the public about the real risks and training requirements of their product in order to reach the highest sales margin possible. It is crucial to know the facts of a given procedure, and those facts may not always be easy to find. Borchardt Law Firm is committed to defending the rights of those who may have suffered devastating injuries from defective medical devices.
At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one has ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.
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