Incident #1528
AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty
Description
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.
Actors
Alleged Deployers
- surgical-teams-using-trudi-navigation-system
- marc-dean
Alleged Developers
- integra-lifesciences
- ai-enabled-surgical-navigation-system-developers
- ai-enabled-healthcare-system-developers
- acclarent
Harmed Parties
- surgical-patients
- patients-undergoing-ai-guided-procedures
- patients
- donna-fernihough
- balloon-sinuplasty-patients