Surgeons Report Da Vinci Robot Surgery Problems in FDA Survey

Hospitals are attempting to improve training for the da Vinci surgical system due to a rising number of reports about deaths, injuries and malfunctions linked to the robotic surgery system made by Intuitive Surgical Inc., according to Bloomberg News Service. Reports of da Vinci robot surgery problems to the U.S. Food and Drug Administration (FDA) increased from 3,697 reports received through November 3, as compared with 1,595 reports received through all of 2012.

Causes of the problems, according to a survey of surgeons by the FDA, include the fact that the complex robot interface was a challenge to master, and inconsistent physician training. The surgeons suggested doctors need time to learn how to use the device’s foot pedals and perform operations. Two urologists said patient safety was “directly related to the surgeon’s training experience,” according to the FDA report.

All but one of the surgeons reported having trouble with the robot’s arms, which sometimes had to be repaired or replaced.

Da Vinci robot surgery problems include inadequate training for doctors

“Training for robotics has been the wild, wild west for a long, long time,” Jeff Berkley, chief executive of Mimic Technologies Inc., which makes simulators used for robotic training, told Bloomberg. With da Vinci robotic surgery lawsuits on the rise, hospitals and doctors’ organizations are understanding “they have to get their act together and start focusing on training.”

Standardized training on new medical technologies “is a systemic problem,” said Robert Sweet, a medical training expert at the University of Minnesota, in a telephone interview with Bloomberg. He said this spotlight on robotic surgery may help bring needed attention on this issue. The main problem will be paying for and overseeing the training of widely scattered physicians, Sweet said.

In response to the study, an Intuitive spokesperson said additional training is available to physicians.

“We don’t let inadequately trained people fly airplanes and excuse it by saying that added training is available for pilots who request it,” Erik Gordon a professor at the Ross School of Business at the University of Michigan in Ann Arbor wrote to Bloomberg in an e-mail.

The FDA incident reports about the da Vinci surgery system include injuries and deaths linked to operations, as well as malfunctions where no injury occurred. The FDA estimated the surge in reports of adverse incidents may be related to improved public awareness due to recent media reports and recalls and more use of the da Vinci surgical systems. These adverse incident reports can be sent to the FDA by companies, medical professionals and patients. They can serve as a warning that U.S. regulators should look more closely at a product.

The results of the FDA survey of eleven surgeons who have performed from 70 to 600 robot surgeries were that the robots resulted in fewer complications and shorter recoveries but they also reported a variety of negative complications, which could lead to da Vinci robotic surgery lawsuits.

da Vinci robot complications may include:

• Reversible limb palsy
• Temporary nerve damage in the fingers
• Bleeding from perforated bowels
• Peripheral vision loss

Marketing & reporting practices scrutinized

Intuitive has faced increased scrutiny this year over the marketing, cost effectiveness and safety of its robots. In July, the FDA sent to the company a warning letter after an inspection revealed a lacking reports of adverse events and device corrections.  Critics say the rising use of robotic surgery has been fueled by aggressive marketing tactics by the company, as well as doctors and hospitals who feel they gain a competitive edge from their use.

Meanwhile, the manufacturer of the robotic surgical system faces about fifty lawsuits from patients who allege injuries caused by da Vinci.