Robo-Surgeries Attract FDA Scrutiny

Robotic surgery was hailed as a big breakthrough when introduced 12 years ago.

Apr. 12, 2013 — -- When robo-surgery was first introduced 12 years ago, it was hailed as a major breakthrough.

They were billed as high-precision robots that were steadier than the human hand, equipped with tiny forceps capable of peeling the skin off a grape, that could operate in tighter spaces than any doctor. Perhaps, most importantly, the technology was touted as having better and safer medical outcomes for patients.

Dr. Warren Kortz of Denver has performed hundreds of operations using robots. On his hospital's website, the Porter Robotics Institute, which is part of Porter Adventist Hospital, robotic surgeries are promoted as the safer, less invasive option.

But the Colorado medical board this week charged Kortz with unprofessional conduct, citing complications in 11 robotic surgeries from 2008 to 2010. In one instance, the robot he was using in the surgery allegedly tore the aorta of a kidney patient.

Kortz and his lawyer declined ABC News' requests for comment.

It is hardly an isolated case of alleged mistakes during robo-surgery.

The Food and Drug Administration announced this week that it is looking into the increasing number of serious medical problems, even deaths, where robotic surgery might have played a role.

Some of the cases suggest errors by the doctor controlling the robotic device, while others could have been caused by the device having gone awry.

"There have been rare cases where during an operation when there needs to be emergency CPR, or an emergency conversion to an open operation, where the robot has gotten in the way," Dr. Mark Makary, a surgeon at Johns Hopkins Hospital in Baltimore, told ABC News.

Incidents this year the government is investigating include a hysterectomy operation, during which the doctor lost control of the robotic forceps. In another operation, the robot tore the patient's bowel, leading to an emergency surgery two days later, and the death of the patient.

Even so, the number of robotic operations has exploded, to about 450,000 last year from about 25,000 in 2005.

Some critics, physicians like Dr. Makary among them, say that in most instances, robotic surgery is no better than conventional surgery. Some of his surgeries are performed with the robot, but not all.

"The vast majority of these studies have shown that there's no benefit to patients for most applications," Makary said. "There's probably only a small set of procedures where there is a benefit.

Makary says robo-surgeries cost as much as $5,000 more than the same surgery done traditionally, by the hands of a surgeon. He also asserts that robo-surgery can take longer, meaning the patient could be under general anesthetic for a greater period of time, which is not ideal.

Reports of complications involving robo-surgery pushed Massachusetts health officials to send hospitals an "advisory" letter in March citing safety concerns. Some doctors have utilized the heavily marketed robots to perform surgeries that might exceed the capabilities of the machine, the operating surgeon, or both, according to officials.

Not all surgeries are the same, and some operations might be better executed with robotic surgery than others.

In certain operations such as colorectal procedures, head or neck surgeries, and heart-valve procedures, some doctors describe being able to get into tighter spaces, benefitting from a greater degree of freedom the robotic hands afford them when compared to minimally invasive surgery.

The equipment is also expensive.

The only surgical robot on the market approved by the FDA is the da Vinci surgical system, made by Intuitive Surgical Inc. of California, with each unit costing roughly $1.45 million or more, and a hefty annual service agreement to the tune of at least $100,000.

More than 2,585 da Vinci Systems are installed in more than 2,025 hospitals worldwide, according to its website.

"The FDA routinely asks medical device companies and hospitals for information, clarification or additional data as part of post market surveillance," Intuitive Surgical said in a written response to ABC News. "Intuitive's highest priority is and always has been to provide patient benefit -- creating products that in a surgeon's hands are safe, effective and minimally invasive.

"Intuitive Surgical issued a statement on March 13, 2013 responding to questions about a recent rise in Medical Device Reports (MDR) filed by the company, which clarifies that it changed reporting practices and therefore saw an increase in MDRs (none involving reportable injury or death).

"For context, the da Vinci Surgical System has an excellent safety record with more than 1.5 million surgeries performed globally and total adverse event rates have remained low and in line with historical trends."