• The Colorado Board of Medical Examiners has charged the doctor with unprofessional conduct.
• The facility suspended the doctor’s privileges at one point.
• Managers should ensure surgery with high-tech devices receives the same oversight as any other procedure.
(In this first part of a two-part series, we discuss the case of a surgeon investigated for his robotic surgeries and how the facility became involved. Next month, we’ll discuss how facilities can manage risks that come with cutting-edge technology.)
A Colorado surgeon is under investigation for 14 robotic surgeries with poor outcomes or adverse events, and the Food and Drug Administration (FDA) is investigating what might be an unexpectedly high rate of problems with surgical robotics. In response, a malpractice attorney is cautioning that high-tech treatments with great marketing potential can lead some facilities to overlook problems on which they might otherwise act.
The Colorado Board of Medical Examiners has charged Warren Kortz, MD, of with 14 counts of unprofessional conduct after failed procedures with the robotic surgery arm owned by Porter Adventist Hospital in Denver. According to the complaint filed by the board, from 2008 to 2010 Kortz cut and tore blood vessels, left sponges and other instruments inside patients after closing, injured patients through improper padding and positioning, subjected some to overly long surgeries, and had to abort kidney donations because of mistakes.
The board also alleges that Kortz failed to properly document some of those problems. The state is asking an administrative judge to suspend Kortz’s license to practice medicine. In a related development, the FDA announced recently that it is investigating robotic surgery devices in response to reports of accidents and adverse outcomes. The FDA has received reports of at least five deaths involving robotic surgery since early 2010, but a statement from the FDA says the agency does not yet know if there is any trend or if robotic surgery is responsible for the deaths or other problems. “Since it is difficult to know why the reports have increased, the FDA has elected to talk with surgeons to better understand the factors that may be contributing to the rise in report numbers,” the statement says.
The FDA database of problems related to medical devices includes 500 reports since Jan. 1, 2012. Some are duplicates, reported by the hospital and the manufacturer, and there is no evidence that any of the problems were caused by the robot. Many of the reports did not involve a patient injury.
Facilities and device makers are required to report adverse outcomes related to medical devices, but the increase in reports could reflect only wider use. Intuitive Surgical in Sunnyvale, CA, which makes the popular da Vinci surgical arm, reports that in 2012 there were 367,000 robot surgeries versus 114,000 in 2008. The da Vinci is the only robotic system cleared for soft-tissue surgery by the FDA, but other robotic devices are approved for neurosurgery, orthopedics, and other procedures.
The Denver hospital is entangled in the Porter case partly because it knew of problems with Porter’s robotic outcomes, explains Daniel P. Slayden, JD, a partner with the law firm of Hinshaw & Culbertson in Joliet, IL, which handles medical malpractice. The hospital issued a statement confirming that it suspended Kortz’s robotic-surgery privileges for three months in 2010. The medical board’s complaint states that the hospital reported Kortz had complications with 11 surgeries using a hospital robot.
Slayden notes that many of the patient complaints against Kortz related to informed consent, with some claiming that he did not properly explain the risks of the robotic procedure or offer a traditional surgery option. That issue is one for the physician rather than the hospital, he says.
"It could become a hospital issue, though, if the plaintiff shows when the doctor started having too many accidents, too many poor outcomes, a higher return-to-surgery rate and asks why the hospital didn’t suspend him until 2010,” Slayden says. “If the data show that his rates were higher than the average, and especially if they were higher when using the robotic arm, someone is going to argue that you should have suspended him in 2009. That’s when it becomes a hospital risk management issue.”