The da Vinci Surgical Robot has no shortage of problems, as multiple lawsuits have already been filed over the device, accusing the manufacturer of producing defective equipment, rushing doctors’ training, and aggressively marketing the device with little heed to patients’ actual needs. Still, there’s no denying that the robot has also enjoyed success, aided in groundbreaking and often successful surgeries that changed the lives of patients across the world. There’s a lot of attention on the remote-controlled robot at the moment, with or without the possibility of legal action.
One attorney in Louisiana identified about 20 patients who were harmed with robotic surgery.
A recent study from John Hopkins, published in Journal of Healthcare Quality, has suggested that the number of complications and problems associated with the da Vinci device might actually be much higher – and that underreporting is clouding the facts. Using three different databases used to log problems – the legal records of PACER, the FDA’s MAUDE system, and LexisNexis – researchers compared reports related to Intuitive Surgical’s headline-grabbing device. The FDA, they found, received 245 reports over twelve years, a period in which more than one million surgeries were performed. The number, the report says, seemed strangely low. Double-checking with the separate databases flagged a further eight injuries not reported to the FDA, or reported late or inaccurately. A small number, perhaps, but a sure sign that the system is not without its flaws and that cases do slip through the cracks.
Another concern, the researchers noted, was that two of the eight reports were filed only after cases were brought to wider media attention – including, in one case, The Wall Street Journal.
The team was lead by Dr. Marty Makary, a laparoscopic pancreas surgeon. Of the eight cases that were not properly reported, three were either filed late or filed in an improper manner and five were missed out of MAUDE (Manufacturer and User Facility Device Experience), raising concerns that other severe problems were simply overlooked by official counts.
Dr. Makary added that within medical circles it was common knowledge that complications often arose with the da Vinci robot, and that he had personally heard of dozens of such complications. This further casts doubt on the accuracy of the 235 reported incidents.
"We know one attorney in Louisiana who identified about 20 patients who were harmed with robotic surgery, and filed a malpractice claims, and if the 245 is accurate, then he must—just in his region—have 10% of all the complications that have occurred from the robot over the last decade. That's a data point that makes you think this number is just far too low," Dr. Makary recently told Health Leaders Media.
Of the incident reports received by the FDA, 71 patients died and 174 suffered injuries of some sort following robotic surgery. Some physicians have begun calls for a robot surgical registry to improve accountability and incident reporting, and to ensure patient safety is as guaranteed as possible. The FDA, meanwhile, announced earlier this year that it would begin surveying medical professionals to gather information on the device’s use and effectiveness. A recall was issued in July for certain parts.
While Intuitive Surgical remains adamant that its surgical robots are safe and effective when used properly, this may not be enough to dissuade critics. For now, though, the investigations continue – as, indeed, do the lawsuits.