Only 245 cases of patient harm in surgeries using the Da Vinci robot system have been reported to the FDA since 2000. The figure seems "very, very low" to researchers, who have identified eight cases of patient harm or death that were not in the FDA's database.
Injuries and death resulting from the minimally invasive Da Vinci surgical robot, which has been used on more than one million patients since 2000, have got to be far more numerous than the 245 cases reported to the U.S. Food and Drug Administration so far, Johns Hopkins University researchers contend.
The team, led by laparoscopic pancreas surgeon Marty Makary, MD, drew that conclusion because he and his research team were able to find eight cases of patient harm or death from robot complications in public court records or media reports.
But no report was made to the FDA's Maude (Manufacturer and User Facility Device Experience) database for five of those cases and for the other three, the report was improperly filed or filed late, after the adverse event was reported by a major newspaper.
"If 60% of those very severe cases were not reported to the FDA, probably many more of less severe or more routine complications were also not reported," Makary says.