Surgical robot maker Intuitive Surgical (NSDQ:ISRG) responded today to news of the FDA’s inquiry into an increase in reported complications with the da Vinci system, claiming that the apparent rise in incidents is a reflection of new reporting practices rather than a change in product performance.
"In September 2012, Intuitive Surgical revised its MDR practices, resulting in increased reports of device malfunction MDRs, the vast majority of which were related to instruments and not to systems," according to a press release. "None of these device malfunction MDRs involved reportable injuries or deaths."
ISRG shares took a serious hit when rumors spread that its da Vinci robot-assisted surgery system was under investigation by the FDA. The federal watchdog agency sent a survey to doctors who use the device, asking for details on any complications and for input on the device’s best use and training program.
The company explained that the apparent rise in adverse events for the da Vinci was due to an "administrative change" in reporting which will also result in an increase to events in the "serious injury" group.
"This change has not increased the total number of adverse event reports," according to a press release. "Total adverse event rates have remained low and in line with historical trends."
Intuitive Surgical representatives were not immediately available to comment.
ISRG shares have not yet clawed their way back from the 11% drop they suffered on February 28, when shares went from an opening price of $573.44 to close at $509.89. Shares were trading at $513.11 as of about 11:40 a.m. today.