AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty

May 19, 2023

On May 19, 2023, patient Donna Fernihough allegedly sustained carotid-artery damage and a same-day stroke during a balloon sinuplasty in Texas. The procedure involved surgeon Marc Dean using Acclarent's AI-enabled TruDi Navigation System, whose AI-assisted navigation was reportedly linked to unsafe guidance during the operation.

Acclarent and Integra LifeSciences, which later acquired Acclarent, have denied any evidence connecting TruDi's AI to the injuries. Through JOIN US, stay informed about this ongoing investigation into AI safety in medical procedures.
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 parties
surgical-patients, patients-undergoing-ai-guided-procedures, patients, donna-fernihough, balloon-sinuplasty-patients

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Source

Data from the AI Incident Database (AIID). Cite this incident: https://incidentdatabase.ai/cite/1528

Data source

Incident data is from the AI Incident Database (AIID).

When citing the database as a whole, please use:

McGregor, S. (2021) Preventing Repeated Real World AI Failures by Cataloging Incidents: The AI Incident Database. In Proceedings of the Thirty-Third Annual Conference on Innovative Applications of Artificial Intelligence (IAAI-21). Virtual Conference.

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