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May 19, 2023Confirmed

Lawsuit alleges AI surgical navigation system contributed to patient's stroke during 2023 sinus procedure

Rogue: Caused harmAI loose in the worldPhysical safetyDERIVED

Approved by person, Oct 11, 2026. How entries are approved

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A patient alleges she suffered carotid-artery damage and a same-day stroke during a May 19, 2023 balloon sinuplasty in Texas. The surgeon reportedly used Acclarent's AI-enabled TruDi Navigation System. Her lawsuit says the AI-assisted navigation contributed to unsafe guidance. Acclarent and Integra LifeSciences deny evidence linking the AI to the injuries.

What this means for youIf you or a family member has surgery, you can ask whether AI-assisted tools are used and how the surgeon checks their guidance. The claims are allegations in a lawsuit and are denied by the companies.

Sources

Data from the AI Incident Database (incidentdatabase.ai), licensed CC BY-SA 4.0 (https://creativecommons.org/licenses/by-sa/4.0/). McGregor, S. (2021) Preventing Repeated Real World AI Failures by Cataloging Incidents: The AI Incident Database. IAAI-21.

Source data license: CC BY-SA 4.0 (database). Report contents keep their own rights; reports.text, submissions, images and videos are excluded from the data license.

rogue:R4

Covered by snapshot 45

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Lawsuit alleges AI surgical navigation system contributed to patient's stroke during 2023 sinus procedure | Vigilo AI Watch