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FDA looking into safety of surgical robots

South Carolina patients undergoing surgery may be interested in a recent urgent medical device recall issued by Intuitive Surgical, Inc., the manufacturer of the da Vinci robotic surgery system. Reportedly, the da Vinci's instrument arms can stall briefly due to friction within the arm. The machine can then move quickly in an effort to correct its position when resistance is overcome. The recall covers nearly 1,400 units around the world.

The da Vinci, which costs approximately $1.5 million, allows human surgeons to cut more precise incisions by operating the robot from a nearby computer control center. The robot is used for a number of different procedures, including prostate removal and gallbladder removal. Its use has spiked in recent years, with a 400 percent increase in the number of medical procedures performed by, or with the assistance of, a da Vinci robot between 2007 and 2011. The robots have participated in more than a million surgeries since 2000, with only 245 complications and 71 deaths reported to the Food and Drug Administration.

Doctors point out that the da Vinci robots are at least as safe as the alternatives, which include open surgery and laparoscopic surgery. A surgery professor at Johns Hopkins School of Medicine said the number of complications was very low, given the large number of surgeries performed. The FDA, though, has stated that the number of robotic surgery "adverse event reports" has doubled over the past year. This sharp increase in negative incidents led to the FDA investigation.

A spokesperson for the FDA said the spike in reporting could be an effect of more widespread use of the technology, or it may be that hospitals and doctors are more aware of issues. Any problem with such sophisticated medical technology could lead to serious injury. A medical malpractice attorney could assist those who have suffered from surgical errors by subpoenaing hospital records and interviewing medical staff.

Source: Med City News, "FDA investigating surgical robot used at three hospitals after ‘urgent medical recall'", Jackie Farwell, December 06, 2013

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