NEW YORK — A rising number of reports about deaths, injuries and malfunctions linked to the robotic surgery system made by Intuitive Surgical may pressure hospitals to bolster training for doctors using the $1.5 million device.
The Food and Drug Administration received 3,697 adverse event reports through Nov. 3, compared with 1,595 through all of 2012, an agency official said in an interview.
While the FDA said the surge may be tied to added public awareness from more use of the machines or recent media reports and recalls, a survey of surgeons released the same day suggested the complex robot interface was a challenge to master and that physician training was inconsistent.
Standardized training on new medical technologies “is a systemic problem,” said Robert Sweet, a medical trainer at the University of Minnesota.
“Training for robotics has been the wild, wild west for a long, long time,” Jeff Berkley, chief executive of Mimic Technologies, which makes simulators used for robotic training. With patient lawsuits on the rise, hospitals and doctor organizations are realizing “they have to get their act together and start focusing on training.”
The main problem will be how to pay for and oversee the training of widely scattered physicians, Sweet said.
In robot-assisted surgery, a physician sits at a video- game-style console several feet from the patient and peers into a high-definition display. Foot pedals and hand controls move mechanical arms equipped with tools, guided by a 3-D camera that shows the work as it is done inside a patient.
The doctor survey released by the FDA on Nov. 8 included 11 surgeons who have performed from 70 to 600 robot surgeries each. While the physicians, who weren’t identified, said the robots led to fewer complications and shorter recoveries, they also reported diverse patient problems. These included reversible limb palsy, temporary nerve damage in the fingers, bleeding from perforated bowels and peripheral vision loss.
Adverse incident reports can be sent to the FDA by companies, medical professionals and patients. While they are largely unverified by the agency, they can sometimes serve as a first-alert that U.S. regulators should look more closely at a product.
While Intuitive was “pleased with the surveyed surgeons’ very positive observations about the benefits of robotic surgery, this small informal survey cannot serve as the basis for any scientifically valid conclusions,” Angela Wonson, a spokeswoman said in the Nov. 8 company statement.
Intuitive has faced scrutiny this year over the marketing, cost effectiveness and safety of its robots. In July, the company received an FDA warning letter after an inspection found it hadn’t adequately reported adverse events and device corrections. It also faces about 50 liability lawsuits from patients who allege injuries tied to the robot
“We don’t let inadequately trained people fly airplanes and excuse it by saying that added training is available for pilots who request it,” wrote Erik Gordon, a professor at the University of Michigan in Ann Arbor, in an e-mail.
Bloomberg News reported last month that the rising use of robotic surgery has largely been fueled by aggressive marketing tactics by the company, as well as doctors and hospitals that gain a competitive edge from the use of the robots.
This includes advertising that, in some cases, inflated the robot advantages by claiming fewer complications without proof and ignored broad-based contradictory studies finding little or no advantage to their use over conventional, less- invasive surgeries.