Posted in News on September 27, 2013

Technological advances in medical instrumentation and equipment have made it possible for hospitals and doctors across the U.S. to perform procedures which were once deemed impossible. In fact, reports indicate that between 2007 and 2011, robotically assisted surgeries increased by 400 percent. It is estimated that one particular system called the da Vinci system performed over a million procedures, and nearly 1,400 of these systems were purchased by hospitals. Nevertheless, despite such advances, surgical errors or errors due to malfunctioning equipment still occur resulting in serious injury to patients.

Montana residents may find it interesting to learn that during an anonymous survey nearly 57 percent of surveyed surgeons who used the da Vinci system reported experiencing irrevocable operative malfunctions with it. A recent article published in the Journal for Healthcare Quality noted that between January 2000 and August 2012 thousands of mishaps related to the da Vinci system were reported to the FDA. Even though in most of the cases the patients did not suffer any harm, about 174 serious injuries and about 71 deaths were reported. Despite this information, researchers at Johns Hopkins concluded that adverse events related to the da Vinci system were significantly underreported.

Generally, both the hospital where the adverse event occurs and the manufacturer of the medical device are required to report all device-related deaths and serious injuries to the FDA within 30-days of finding out about the incident. However, in some cases the events are not reported.

The president of the National Research Center for Women and Families, an expert on the safety of medical devices, noted that very little is known about the true advantage of the system, and the injuries or deaths it may cause. Further, noting that any time there is an issue with this potentially dangerous product and it is reported it the FDA’s task to determine if the problem is with device or due to a doctors error.

Source: The New York Times, “New Concerns on Robotic Surgeries,” Ron Rabin, Sept. 9, 2013