fda taking a closer look at popular robotic surgery system

It can be rather shocking for a patient to learn that he or she will have to undergo a surgical procedure to address an underlying medical issue. It can be even more shocking to learn that this surgical procedure will be performed robotically.

Believe it or not, nearly one out of every four U.S. hospitals is now equipped with a $1.45 million, FDA-approved robotic surgical system called the da Vinci. It is capable of performing a multitude of laparoscopic surgeries, including hysterectomies, gastric bypasses and even organ transplants

The da Vinci system, which has been available to hospitals since 2000, consists of a three- to four-armed robot that is controlled by a surgeon sitting at a computer station located several feet from the patient. These robotic arms are equipped with tiny surgical instruments, including cameras that enable the surgeon to see inside the patient on a television screen.

Advocates of the da Vinci system have long argued that it produces better overall results than traditional surgery, eliminating surgical errors attributable to physician fatigue, shortening patient recovery times and reducing internal bleeding.

The Food and Drug Administration, however, recently announced that it will take a closer look at the da Vinci system after it has seen a significant increase in the number of reported problems and complications associated with its use.

Indeed, sources indicate that a search of an FDA database reveals that at least 500 reports concerning the da Vinci system have been filed since Jan. 1, 2012, and that the majority were filed by its manufacturer, Intuitive Surgical Inc., which is required to report such matters under federal law.

Some of the more shocking reports include a woman dying during a routine hysterectomy in 2012 after one of the robotic arms cut a blood vessel, and a 2013 surgery in which the da Vinci system had to be shut down because one of the robotic clasps wouldn’t let go of a patient’s tissue.

For its part, Intuitive Surgical is arguing that there has not been a real increase in problems with robotic surgery but rather that the increase can simply be attributed to a change in its reporting systems. Still others are theorizing that the jump could be traced to wider use of the da Vinci system or greater awareness among physicians about reporting problems.

Critics of the da Vinci system are nevertheless hopeful that the FDA investigation should at the very least help shed light on the fact that more research is needed into the necessity, efficacy and overall safety of robotic surgery.

In the meantime, it remains to be seen whether hospitals will be deterred from using their da Vinci systems pending the outcome of the FDA investigation. This appears unlikely, however, given that there were nearly 400,000 robotic surgeries performed last year.

Please visit our website if you or a loved one was unjustly harmed by a surgical error or other form of medical malpractice.

Source: CBS News, “FDA eyes increase in freak accidents during robotic surgeries,” April 9, 2013

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