AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

June 23, 2022

In a sinus procedure conducted in Texas, it was alleged that the AI-enabled TruDi Navigation System manufactured by Acclarent misguided surgeon Marc Dean about the placement of his instruments within patient Erin Ralph's head. This malfunction could have potentially contributed to carotid-artery injury and subsequently a stroke. Reuters reported that Ralph filed a lawsuit, accusing the system's AI of contributing to her injuries. Both Acclarent and Integra disputed the causal connection. For more information on ensuring responsible AI implementation in healthcare and contributing to safe and secure AI practices through HISPI Project Cerebellum TAIM (Trusted AI Model), join us—JOIN US.

Matched TAIM controls

Suggested mapping from embedding similarity (not a formal assessment). Browse all TAIM controls

Alleged deployer
marc-dean, surgical-teams-using-trudi-navigation-system
Alleged developer
acclarent, ai-enabled-surgical-navigation-system-developers, ai-enabled-healthcare-system-developers, johnson-and-johnson, integra-lifesciences
Alleged harmed parties
erin-ralph, surgical-patients, patients, patients-undergoing-ai-assisted-procedures, sinus-surgery-patients

AI governance case studies

For forensic AI governance failure analysis (TAIMScore™ case studies), browse Human Signal’s Failure Files™.

Source

Data from the AI Incident Database (AIID). Cite this incident: https://incidentdatabase.ai/cite/1436

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.

Pre-print on arXiv · Database snapshots & citation guide

We use weekly snapshots of the AIID for stable reference. For the official suggested citation of a specific incident, use the “Cite this incident” link on each incident page.