AI-enabled healthcare systems
Incidents implicated systems
Incident 14362 Report
AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure
2022-06-23
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.
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AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty
2023-05-19
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.
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Purportedly AI-Assisted Hospital-Bed Prioritization Allegedly Delayed Intensive Care Before a Patient's Death in Minas Gerais, Brazil
2026-06-06
The family of a 32-year-old patient in Minas Gerais, Brazil, alleged that Core-MG, an AI-assisted hospital-bed allocation system, understated her condition and delayed intensive care. Her sister said the severity score impeded reprioritization. The patient died hours after transfer. The state health department denied a system failure in her case and said physicians assessed patients according to clinical need and bed availability.
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