Intuitive Surgical recently issued a Class II recall on 30 da Vinci surgical robots which may not meet compliance standards because of improper testing.
According to a recent article in Bloomberg, the recall affects the da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box, and Dual Camera Controller. Quoted in the article, Intuitive Surgical spokeswoman Angela Wonson said, “We discovered that one piece of testing equipment wasn’t recording results properly.” No complaints were received, and when the 30 systems were subsequently re-tested in the field, they all passed.
The FDA states that a Class II recall is issued in “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Intuitive Surgical’s da Vinci robotic surgical systems have become the subjects of multiple personal injury lawsuits brought by individuals who claim that the potentially dangerous medical devices led to their severe injury or even the death of their loved one. The robots, which allow surgeons to conduct minimally-invasive laparoscopic surgery, have been blamed for up to 70 deaths since 2009, according to U.S. regulators.
Some believe that inadequate surgeon training is behind many of the reported da Vinci surgical robot injuries and deaths, while others blame poor design for the multiple reports of organ damage, severed blood vessels, and internal burns.
If you suffered a serious injury or the tragic loss of a loved one, and you believe your suffering may be linked to use of the da Vinci surgical robot system, you could be entitled to compensation for medical bills and possible additional damages. For more information on compensation and plaintiffs’ rights in da Vinci robot lawsuits, contact the personal injury lawyers at Berkowitz and Hanna LLC.