Failure of Da Vinci Surgical Systems May Be Obscured By Underreporting
The da Vinci robotic surgery system from Intuitive Surgical has been in the news in recent months due to reports about patients being injured in conjunction with an operation carried out by one of these machines. The Food and Drug Administration has a database in place where such adversity is supposed to be reported, and the agency itself has pledged to look into the matter.
However, a new report from Bloomberg points out the one crucial flaw of the FDA’s database: not every report gets related to the agency in a timely manner. Although hospitals are supposed to file adversity reports, there isn’t a precise mechanism in place to ensure that occurs, and doctors are not even required to make reports.
This often puts the impetus on patients to bring the matter to the forefront, an issue that can often prove difficult. Bloomberg reportedly conducted an investigation that found there were numerous incidents that took years to be reported appropriately. So while Intuitive may be able to cite a dearth of adversity reports when touting the safety of their product, that dearth of reports isn’t as clear-cut as originally thought.
A spokeswoman for the company pointed out that a report of adversity doesn’t necessarily mean the da Vinci was the cause and that they don’t get made aware of situations that aren’t reported by hospital officials.
Among the issues that have been scrutinized is the training of the very physicians who use the da Vinci.