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

In 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence to a medical device used to treat chronic sinusitis, an inflammation of the sinuses. Acclarent said the software for its TruDi Navigation System would now use a machine-learning algorithm to assist ear, nose and throat specialists in surgeries.

The device had already been on the market for about three years. Until then, the U.S. Food and Drug Administration had received unconfirmed reports of seven instances in which the device malfunctioned and another report of a patient injury. Since AI was added to the device, the FDA has received unconfirmed reports of at least 100 malfunctions and adverse events.

At least 10 people were injured between late 2021 and November 2025, according to the reports. Most allegedly involved errors in which the TruDi Navigation System misinformed surgeons about the location of their instruments while they were using them inside patients’ heads during operations.

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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About four years ago, the FDA expanded its roster of scientists who specialize in AI, particularly for reviewing medical imaging and radiology devices that use the technology. Many recruits were stationed in the Division of Imaging, Diagnostics and Software Reliability (DIDSR). The unit became the agency’s key resource for assessing the safety of AI in medicine, one current and two former FDA employees told Reuters. It grew to about 40 people early last year.
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But early last year, the Trump administration began to dismantle the AI team as part of Elon Musk’s cost-cutting campaign, the Department of Government Efficiency, or DOGE. About 15 of the 40 AI scientists in the DIDSR unit were laid off or opted to go, the FDA insiders said. Another unit that crafted policy on devices using AI, the Digital Health Center of Excellence, lost about a third of its staff of around 30.