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WF-4DGQE7

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

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.

Date it happened
2022-06-23
Organisation involved
Marc Dean, Surgical teams using TruDi Navigation System
Product, system or model
TruPath, Acclarent TruDi Navigation System, AI-enabled surgical navigation systems, AI-enabled healthcare systems, Surgical navigation systems
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Attribution

This incident was imported from AI Incident Database and is used under CC BY-SA 4.0. Our additions to it — the structured fields, the translation, the checks against other reports — are published under the same licence.

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