FDA Clears da Vinci Robotic Surgery Firm on Warning Letter

May 02, 2014

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.

As of March 31, there were 2116 da Vinci systems installed throughout the United States and 923 in other countries, according to a recent company filing with the US Securities and Exchange Commission. The number of surgeries performed with the technology in the United States rose from roughly 367,000 in 2012 to 422,000 in 2013. Almost 57% of those in 2013 were hysterectomies, myomectomies, and other gynecologic procedures.

The computerized technology allows a surgeon to manipulate laparoscopic instruments attached to robotic arms while viewing the procedure in 3 dimensions, just as if it were open surgery.

Earlier this year, the FDA approved an upgraded model of the da Vinci robotic surgical system.

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