The TruDi navigation system with artificial intelligence, used for minimally invasive treatment of chronic sinusitis, has found itself at the center of a scandal. The US Food and Drug Administration (FDA) has recorded at least 100 reports of equipment malfunctions, including at least 10 cases of serious injuries — from skull base punctures to cerebrospinal fluid leaks and strokes. The victims have already filed lawsuits against the developer, Acclarent.

Court documents allege that the system misled surgeons about the actual position of instruments in the skull. Plaintiff Erin Ralph claimed that due to erroneous data, the doctor damaged her carotid artery, leading to a blood clot and stroke. A second patient, Donna Fernighough, described a similar scenario — a ruptured artery and emergency surgery.

The incident exposed systemic problems with AI regulation in medicine.