What happened

TruDi Navigation System, a medical device originally used to assist sinus surgery, was upgraded with machine learning AI to provide real-time guidance inside patients’ heads during procedures. 

U.S. Food and Drug Administration (FDA) databases subsequently received over 100 reports of malfunctions and adverse events, including at least ten cases of documented patient injuries between late 2021 and November 2025, including punctures at the base of the skull, cerebrospinal-fluid leaks, major artery damage, and strokes. 

Erin Ralph and Donna Fernihough claimed they were injured in sinuplasty procedures and filed lawsuits in Texas, claiming that the device misled surgeons about instrument location, leading to carotid artery injuries and subsequent strokes. 

Plaintiffs allege the system is “inconsistent, inaccurate, and unreliable", and that safety standards were deliberately lowered to rush the system update to market. 

The device’s current owner argues there is no credible evidence linking the surgical support system to these injuries. 

Why it happened

According to legal filings and regulatory data, the spike in reports followed the addition of machine learning when the manufacturer sought to market the technology as a novel improvement. 

Plaintiffs argue that development and integration prioritised competitive positioning over rigorous validation, setting accuracy targets as low as 80 percent before release, and overlooking surgeon warnings about unresolved issues. 

Meantime, the FDA’s incident reporting system does not confirm causation, highlighting regulatory challenges in assessing AI-driven systems with traditional oversight models. 

Experts also note regulators face resource constraints in evaluating growing numbers of AI-enabled devices.