Johnson & Johnson's TruDi Navigation System, a medical device used in sinus surgeries, experienced significantly increased malfunctions and patient injuries after AI was added in 2021, with at least 10 people injured including two stroke victims from damaged arteries.
In 2021, Johnson & Johnson's subsidiary Acclarent added artificial intelligence to its TruDi Navigation System, a medical device used by ear, nose and throat specialists in chronic sinusitis surgeries. The device had been on the market for about three years before AI integration, during which the FDA received reports of seven malfunctions and one patient injury. After AI was added, the FDA received unconfirmed reports of at least 100 malfunctions and adverse events. At least 10 people were injured between late 2021 and November 2025, with most cases involving errors where the TruDi Navigation System misinformed surgeons about instrument locations during operations inside patients' heads. Specific injuries included cerebrospinal fluid leaking from one patient's nose, a surgeon mistakenly puncturing a patient's skull base, and two patients suffering strokes after major arteries were accidentally injured. Two stroke victims filed lawsuits in Texas alleging the AI contributed to their injuries, with one suit claiming the product was 'arguably safer before integrating changes in the software to incorporate artificial intelligence.' The AI software uses machine learning to identify anatomical segments and calculate surgical paths, designed to provide real-time feedback during procedures.
Domain classification, causal taxonomy, severity scores, and national security assessments were LLM-classified and may contain errors.
AI systems that fail to perform reliably or effectively under varying conditions, exposing them to errors and failures that can have significant consequences, especially in critical applications or areas that require moral reasoning.
AI system
Due to a decision or action made by an AI system
Unintentional
Due to an unexpected outcome from pursuing a goal
Post-deployment
Occurring after the AI model has been trained and deployed
