Reuters Finds AI-Using Surgery Devices Harmed Patients; Nature Magazine and Reuters Find Medical Chatbots Not Beating Patients’ Own Internet Sleuthing
Wednesday, February 11, 2026
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The FDA received unconfirmed reports of at least 100 malfunctions and adverse events related to the TruDi Navigation System, with at least 10 people injured between late 2021 and November 2025, including cases of strokes, cerebrospinal fluid leaks, and skull punctures.
A Reuters investigation found that the TruDi system, which uses AI to assist ear, nose, and throat specialists in surgeries, misinformed surgeons about the location of their instruments, leading to severe injuries, with one patient, Erin Ralph, suffering a stroke after a sinuplasty operation.
At least 1,357 medical devices using AI are now authorized by the FDA, with dozens of other AI-enhanced devices, including a heart monitor and an ultrasound device, coming under question due to reports of overlooked abnormal heartbeats and misidentified fetal body parts, according to researchers from Johns Hopkins, Georgetown, and Yale universities.
