The FDA is investigating the safety of a surgical robot that was used in 367,000 procedures last year, following the documentation of a slew of potentially dangerous errors, reports the Associated Press. Intuitive Surgical’s da Vinci system, a three- or four- armed robot remotely controlled by surgeons, is now in nearly a quarter of US hospitals, but an increasing number of reported potential mishaps — about 500 since last year — has caught the FDA’s attention. Though there’s no official results of the investigation yet, an FDA spokesperson told the AP that the increased quantity of incident reports may simply be a matter of better practices by doctors as they become more aware of the new tool. We’ve reached out to Intuitive Surgical for comment.
FDA investigating safety of widely-used surgical robot following increased incident reports
As the increasing use of robotic surgical systems brings about more opportunities for a glitch to surface, Carnegie Mellon and Johns Hopkins researchers have begun developing ways to prove that a robot is free of errors. The researchers’ new paper details a problem with debugging software for surgical robots; they write, “Testing is useful, but only shows the presence of bugs, not their absence.”
Because such systems are both physical and virtual, analysis has previously been difficult — but the researchers’ new method allows for the modeling and identification of collision errors that shouldn’t exist and could potentially harm a patient. One of the team’s researchers has previously used a similar approach to design systems that work to avoid aircraft collisions. This method is currently only applicable to a specific robot that prevents a scalpel-like tool from reaching outside of a specified surgical area, but future research could see it applied elsewhere.
