Researchers: Injuries linked to Da Vinci surgeries are underreported

Only 245 cases of patient harm in surgeries using the Da Vinci robot system have been reported to the U.S. Food and Drug Administration (FDA) since 2000. The figure seems “very, very low” to Johns Hopkins University 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 1 million patients since 2000, have got to be far more numerous than the 245 cases reported to the FDA so far, the researchers contend.

The team, led by laparoscopic pancreas surgeon Marty Makary, MD, drew that conclusion after finding 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 Manufacturer and User Facility Device Experience database for five of those cases. For the other three, the report was improperly filed or filed late, after the adverse event was reported by a major newspaper.

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