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Adverse Events Linked to da Vinci Surgical Robot More than Double in One Year

Nov 11, 2013

The number of adverse events linked to use of the da Vinci surgical robot has more than doubled so far this year over last year, showing that the device has a growing presence on the American healthcare landscape and, more importantly, that more training for the doctors using it is needed.

In fact, a recent survey conducted by the U.S. Food and Drug Administration (FDA) of surgeons who have performed multiple procedures with the da Vinci surgical robot reveals that training programs designed by Intuitive Surgical Inc., the maker of the da Vinci Surgical System, and approved by hospitals implementing the device’s use are inconsistent from facility to facility and doctor to doctor.

Bloomberg reported recently that the FDA’s adverse events database shows that nearly 3,700 adverse events have been linked to the da Vinci surgical robot this year. That’s well more than double the nearly 1,600 reported for all of 2012.

The reason for the higher number of adverse events could be due to several factors, based on the Bloomberg report. First, more da Vinci surgical robots have been sold in the past year, which means more hospitals are using them. Surgeons are also employing the da Vinci in more procedures. And as more people undergo robotic-assisted procedures, there is a greater that the doctor behind the video console has less experience, which can increase the chance of injury.

From a recent survey of 11 surgeons with varying degrees of experience on the da Vinci, the FDA found that there is a lack of consistency with regards to training, and that most of the surgeons described the da Vinci surgical robot as having a “complex interface” that required mastering, according to the Bloomberg report.

Injuries seen in patients following da Vinci-assisted procedures ranged from the somewhat minor, temporary palsy in the hands, to the more serious and life-threatening, such as perforated bowels, Bloomberg noted.

Based on our reports, perforations and burns caused by the mechanical robotic arms of the da Vinci surgical robot are the root of many serious adverse events linked to the device. These adverse events can include severe and sometimes irreversible bleeding episodes or serious and sometimes permanent damage or disfigurement.

Use of the da Vinci surgical robot is expected to grow even more in the coming years as additional hospitals purchase them and more surgeons are trained to use them.

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