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FDA investigating safety of widely-used surgical robot following increased incident reports

FDA investigating safety of widely-used surgical robot following increased incident reports

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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.

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.