AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure
Description
Patient Erin Ralph allegedly suffered carotid-artery injury and a stroke after a June 23, 2022 sinus procedure in Texas in which surgeon Marc Dean reportedly used Acclarent's AI-enabled TruDi Navigation System. Ralph's lawsuit alleged TruDi misinformed Dean about the instrument's position inside her head; Acclarent and Integra LifeSciences, which later acquired Acclarent, reportedly denied a causal connection.
Actors
Alleged Deployers
- marc-dean
- surgical-teams-using-trudi-navigation-system
Alleged Developers
- acclarent
- ai-enabled-surgical-navigation-system-developers
- ai-enabled-healthcare-system-developers
- johnson-and-johnson
- integra-lifesciences
Harmed Parties
- erin-ralph
- surgical-patients
- patients
- patients-undergoing-ai-assisted-procedures
- sinus-surgery-patients
Classification
Risk Domain
AI Safety & FailuresRisk Subdomain
7.3. Lack of capability or robustness
MIT Risk Profile
Topics
Source
Related Incidents (AI Safety & Failures)
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Mitigation Tools
Tools related to this risk domain, via shared responsible AI topics.