Intuitive Discloses FDA Warning Letter Over Robotic Surgery Lawsuit Complications, Fall in Extended Trading and Reduced Sales Forecast for 2013
Complications alleged in robotic surgery lawsuit filings may be creating a ripple of negative aftershocks for Intuitive Surgical, who disclosed this month the contents of a warning letter from the U.S. Food and Drug Administration (FDA), a reduced sales forecast and decline in extended trading related to its primary product, Bloomberg.com reports.
FDA Warns of Robotic Surgery Complications
The makers of the da Vinci Surgical System received a warning letter from the FDA on July 17th, in which the agency highlighted a number of deficiencies with the device found during April and May inspections, according to a recent report. Not only did Intuitive fail to report patient adverse event reports and device corrections associated with the robot, agency officials also said the company neglected to document the need for surgeons operating the da Vinci robot to clean the instruments during procedures. The company has received robotic surgery complications related to arcing of energized surgical instruments after some surgeons scraped instruments against each other to clean them while surgery was in progress, the agency said.
According to the FDA report, that scraping “led to tears or holes in protective tip covers that led to arcing that in turn led to injuries to patients.”
A Bloomberg report from February showed that the da Vinci surgery robot was tied to 70 deaths since 2009, among injuries including cut ureters, surgical burns and tears to arteries, bowel injuries and organ damage.
Intuitive Sees Slump in Second-Quarter Sales of Robot Possibly Caused by da Vinci Lawsuit Filings
In financial news, Intuitive’s shares fell 12 percent to $370.70 in extended trading after rising 5.9 percent earlier to close at $421.98. The company reported that second-quarter sales of the da Vinci system had sunk from the previous year, which may have been unexpected given Intuitive’s forecasted annual sales growth of 16 percent to 19 percent in January. In April, the company said it expected the higher range.
Intuitive reported sales of da Vinci instruments and accessories rose 18 percent during the second quarter, while revenue from the systems declined 6 percent. The company acknowledged recently that these numbers may reflect the scrutiny surrounding the safety of the remote-controlled robot, which may have led to fewer purchases by hospitals.
Robotic Surgery Lawsuit Filings
A growing number of patients throughout the U.S. are pursuing da Vinci robot lawsuit claims against the manufacturer. Call an attorney at Bernstein Liebhard LLP to find out more about filing a case at (877) 779-1414.