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Intuitive Surgical Issues Latest da Vinci Surgical Robot Field Correction Notice

Dec 4, 2013

More trouble with the da Vinci surgical robot has prompted yet another warning from the maker of the device—as well as federal health regulators.

Both the U.S. Food and Drug Administration (FDA) and Intuitive Surgical Inc. have issued a Field Correction Notice for the da Vinci surgical robot due to a malfunction with the device's operating "wrist" that could result in serious patient injuries.

In recent reports, we've noted several problems with the da Vinci surgical robot that have resulted in patient injuries or deaths. In some cases, device error leads to patient injuries. In other cases, an inexperienced surgeon is suspected of making an error that results in serious injuries.

To date, thousands of reports filed with the FDA's MAUDE adverse events database blame a procedure using the da Vinci surgical robot for serious injuries or deaths. In our reports, we've noted injuries ranging from severe bleeding to other internal injuries, including burns and perforation of organs and blood vessels nicked by a tertiary tool that the surgical robot had been using during a procedure.

According to a statement from Intuitive Surgical Inc., the da Vinci is capable of stalling during a procedure if excessive friction is created during the surgery. The company says this has been an issue in three surgeries so far, based on reports filed with the federal database. No injuries have resulted.

The "field notice" from Intuitive is specific to the da Vinci S, Si, and Si-e System and its Patient Side Manipulators (PSMs) on the Patient Side Cart.

"The company is taking this action after becoming aware that excessive friction within certain instrument arms could interrupt smooth instrument motion, which is felt as resistance by the surgeon. If a surgeon pushes through the resistance, the instrument could stall momentarily and then suddenly catch-up to the correct position," Intuitive notes in its statement.

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