Da Vinci Robot Comes Under Scrutiny

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Many of the organizations HCE has interviewed over the years have invested millions of dollars in the popular da Vinci surgical robot. When asked, these organizations almost always give the robot positive reviews and feel the investment was worthwhile.

However, as The Associated Press reports, “The Food and Drug Administration is looking into an increase in reported problems, including deaths during robotic surgeries. Its medical-device database lists dozens of problems and at least five deaths since early last year.”

Whether there’s “a real connection” between these deaths and the da Vinci robot or not is very much in question. Some critics believe there are other causes for alarm, though.

As the AP reports in another article,  “There also have been a few disturbing, freak incidents: a robotic hand that wouldn’t let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.”

Even though the number of surgeries using the robot has tripled in four years, hitting an all-time high of 367,000 surgeries last year, there is still division in the medical community over whether these robots are novelty trends or truly a futuristic breakthrough.

As the AP suggests, some doctors are cynical about the overall acceptance of the product, classifying the robot’s expanding popularity as a classic case of jumping aboard the proverbial bandwagon, thanks to exceptional marketing from da Vinci’s manufacturer, Intuitive Surgical Inc. Some, in the words of Johns Hopkins surgeon and co-author of an upcoming research paper on robotic-surgery complications Dr. Martin Makary, assert, “The rapid adoption of robotic surgery…has been done by and large without the proper evaluation.”

Regardless of the product’s critics, many physicians see the da Vinci robot as a godsend and have used it in “removing prostates, gallbladders, and wombs, repairing heart valves, shrinking stomachs, and transplanting organs. “

According to the AP, “For surgeons, who control the robot while sitting at a computer screen, these operations can be less tiring. Plus robot hands don’t shake. Advocates say patients sometimes have less bleeding and often are sent home sooner than with conventional laparoscopic surgeries and operations involving large incisions.”

It is wholly possible that the increased problems with the robot could just be a result of more people using the technology, many of whom may not be as knowledgeable of the robot’s functions and applications as they should be.

The AP writes, “Intuitive Surgical disputes there’s been a true increase in problems and says the rise reflects a change it made last year in the way it reports incidents.”

Company spokeswoman Angela Wonson said the robot “has an excellent safety record with over 1.5 million surgeries performed globally, and total adverse event rates have remained low and in line with historical trends.

We’ll continue to keep an eye on the FDA’s investigation as it develops. In the meantime, if you’re organization uses the da Vinci robot, what have been your experiences with the technology? What lessons have you learned and how has it benefited your provision of care?

-by Pete Fernbaugh

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