AI incident #1528 ·
AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty
What happened
Patient Donna Fernihough allegedly suffered carotid-artery damage and a same-day stroke during a May 19, 2023 balloon sinuplasty in Texas in which surgeon Marc Dean reportedly used Acclarent's AI-enabled TruDi Navigation System. Her lawsuit alleged the system's AI-assisted navigation contributed to unsafe guidance during the procedure; Acclarent and Integra LifeSciences, which later acquired Acclarent, denied evidence linking TruDi's AI to the injuries.
Only the incident metadata is stored here. The underlying news reports are on the AI Incident Database (CC BY-SA 4.0); use the links above to read them.
News reports (2)
Coverage catalogued by the AI Incident Database. Titles link to the original publisher; the text is not reproduced here.
Who was involved
- Alleged deployer
- Surgical Teams Using Trudi Navigation System, Marc Dean
- Alleged developer
- Integra Lifesciences, Ai Enabled Surgical Navigation System Developers, Ai Enabled Healthcare System Developers, Acclarent
- Alleged harmed party
- Surgical Patients, Patients Undergoing Ai Guided Procedures, Patients, Donna Fernihough, Balloon Sinuplasty Patients
Classification (MIT AI Risk Repository taxonomy)
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