As AI enters the operating room, reports arise of botched surgeries and misidentified body parts [View all]

Source: Reuters

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Cerebrospinal fluid reportedly leaked from one patient’s nose. In another reported case, a surgeon mistakenly punctured the base of a patient’s skull. In two other cases, patients each allegedly suffered strokes after a major artery was accidentally injured.

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The TruDi software uses machine learning to identify specific segments of a patient’s anatomy and calculate “the shortest, valid path between two points specified by the physician,” according to an Acclarent post on LinkedIn. The technology is designed to simplify surgical planning and provide real-time feedback during procedures such as sinus operations.

Acclarent officials had approached Dean about the plan to add AI, the Fernihough suit states. The surgeon warned Hopkins and Acclarent “that there were issues that needed to be resolved,” the complaint adds. Despite that warning, the suit claims, Acclarent “lowered its safety standards to rush the new technology to market,” and set “as a goal only 80% accuracy for some of this new technology before integrating it into the TruDi Navigation System.”

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The FDA requires clinical trials for new drugs, but medical devices face different screening. Most AI-enabled devices coming to market aren’t required to be tested on patients, according to FDA rules. Instead, makers satisfy FDA rules by citing previously authorized devices that had no AI-related capabilities, says Dr. Alexander Everhart, an instructor at Washington University’s medical school in St. Louis and an expert on medical device regulation.

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Read more: https://www.reuters.com/investigations/ai-enters-operating-room-reports-arise-botched-surgeries-misidentified-body-2026-02-09/