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Intuitive Surgical May Not Have Tested Devices Properly

Intuitive Surgical May Not Have Tested Devices Properly

Intuitive Surgical Inc., the maker of the da Vinci Surgical System robots, informed customers that 30 devices may not have been tested properly, according to the U.S. Food and Drug Administration.

The FDA, calling it a “class 2 recall,” said the action affects Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller, in notices posted on its website yesterday. Factory testing on the systems may not meet compliance standards, the regulator said. Intuitive sent the Urgent Device Correction notice to all affected customers on June 27, the FDA said.

“We discovered that one piece of testing equipment wasn’t recording results properly,” Angela Wonson, an Intuitive spokeswoman, said in an e-mailed statement. The 30 systems were re-tested in the field. “All systems have passed,” she said. No complaints were received.

Intuitive, based in Sunnyvale, California, sold 143 da Vinci Surgical Systems in the second quarter, generating $215 million in sales, according to a statement earlier this month. The FDA defines a class 2 recall as “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.”

Bloomberg News reported in February that U.S. regulators were surveying surgeons about the robots following a rise in adverse event reports that include as many as 70 deaths since 2009. The reports, from doctors, patients and companies, don’t necessarily mean the robots caused any deaths, only that they were involved in procedures in which deaths occur.

Intuitive fell less than 1 percent to $429.04 at the close in New York. The shares have declined 13 percent this year.

(Updates with Intuitive statement in third paragraph.)