Robot-assisted surgical systems maker Intuitive Surgical (NSDQ:ISRG) called out the authors of a study published in the Journal for Healthcare Quality, saying that their conclusion that robot-related surgical complications were under-reported is "misleading."
The report, conducted by Johns Hopkins researchers, highlighted 245 FDA-reported adverse events associated with robots in the operating room surgery, including 71 deaths.
The researchers said that, considering that more than 1 million robot-assisted surgeries have been performed in the U.S. since 2000, adverse events must be dramatically under-reported. The report further suggested that some adverse events had only been officially reported after getting media attention.
Intuitive Surgical objected to the conclusions, maintaining that the company had always faithfully and fully reported adverse events to the proper authorities, noting that complications experienced in the operating room may not always make it back to the manufacturers.
"The Journal for Healthcare Quality article gives the misleading impression that Intuitive Surgical has systematically failed in its obligation to timely report known adverse events to the FDA," according to a company statement. "Intuitive Surgical can only report adverse events after it becomes aware of them."
Intuitive Surgical, a market leader with its da Vinci robot, has been navigating troubled waters with a 30% decrease in stock price since February and a recent Class II recall of some da Vinci products.
Share prices plunged earlier this summer after the company revealed anemic Q2 numbers and lowered full-year forecasts.