NEW YORK – The number of adverse incident reports involving Intuitive Surgical Inc.’s robots has more than doubled this year, according to U.S. regulators, who just released a physician survey showing no consistent training exists for the machines, which are also used in Japan.
The Food and Drug Administration received 3,697 adverse reports through Nov. 3, compared with 1,595 in 2012. The surge, though, doesn’t necessarily mean the rate has changed, said William Maisel, with the FDA’s device unit. Rising robot use in the United States and Japan, along with recent media reports and recalls, may have spurred public attention, he said. The reports, issued by the company and medical professionals, are largely unverified by the agency.
The FDA survey released Friday included 11 doctors who have performed from 70 to 600 robot surgeries each. While they said the device led to fewer complications and shorter recoveries, they reported incidents in which robot arms collided or missed their mark and noted training was an issue.
The FDA didn’t draw conclusions on the device because of the survey size. “All respondents report that learning how to use the da Vinci Surgical System is the biggest challenge because of the device’s complex user-interface,” the FDA said in a report on the survey, which reveals a wide variety of training experiences for doctors in four different specialties.
The 11 doctors also reported diverse patient complications, including reversible limb palsy, temporary nerve damage in the fingers, bleeding from perforated bowels and peripheral vision loss.
“While we are 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 for Sunnyvale, California-based Intuitive, said in a statement. “Large clinical studies have documented the comparative benefits of robotic surgery.”
In January 2012, a hospital in Toyoake, Aichi Prefecture, announced it would launch a training center for the da Vinci Surgical System that year (www.japantimes.co.jp/news/2012/01/14/news/aichi-hospital-to-launch-training-center-for-robot-assisted-surgery) That followed the death of a cancer patient after a da Vinci-assisted operation at Nagoya University Hospital in September 2010 that was blamed on lack of training.
Additional training is available for surgeons who request it, Wonson said, “in many forms — from the manufacturer, from their hospital and from surgical societies.” Referring to comments that some doctors weren’t generally aware of recalls, she said they may not have been using the precise products recalled at a given time.
Intuitive, which received Japanese approval nearly four years ago, has faced scrutiny this year over the marketing, cost effectiveness and safety of its robots, which cost $1.5 million apiece. In July, it 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.
Bloomberg News reported last month that the rising use of robotic surgery has largely been fueled by aggressive marketing tactics by doctors and hospitals that gain a competitive edge from the use of the robots. This includes widespread ads that, in some cases, inflated the merits by claiming fewer complications without proof and ignored broad-based contradictory studies that found little or no advantage over similar noninvasive surgery.
Since Bloomberg News first reported the existence of the FDA survey, Intuitive’s shares have fallen 32 percent. On Oct. 17, Intuitive reported a decline in third-quarter profit as a result of lower sales.
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 in the patient.
The FDA incident reports include injuries and deaths linked to robotic surgery operations, as well as malfunctions where no injury occurred. It first began looking at adverse events linked to the robots in 2011, when there were just 511 reports, said Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health.
The surgeons surveyed suggested doctors need time to learn how to use the foot pedals and perform operations. Two urologists said patient safety was “directly related to the surgeon’s training experience,” the report said.
All but one of the surgeons reported having trouble with the robot’s arms, which sometimes had to be repaired or replaced. Only three were aware of recalls related to the device.
In gynecology, the doctors told the FDA the da Vinci system is particularly well suited for hysterectomies for patients with cancer or for uterus-preserving surgery to remove fibroids.
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