DaVinci Robotic Surgery Lawsuits
The wheels of regulation grind slowly, but the US Food and Drug Administration (FDA) last week finally declared that the maker of the da Vinci robotic surgical system has satisfactorily addressed violations listed in an agency warning letter from July 2013.
Among other things, the FDA faulted Intuitive Surgical, the manufacturer of the robotic surgical system, of neglecting to report “field actions” it took to guard patients from accidental electrical burns. The agency also said that company did not comply with requirements for documenting equipment design. The warning letter came on the heels of FDA inspections of the company’s headquarters in Sunnyvale, California, in the spring of 2013.
In a letter dated April 25, 2014, an FDA compliance officer informed Intuitive Surgical that the company’s corrective actions in response to the 2013 warning letter appeared to pass muster.