Description: 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.
Editor Notes: See case information for Fernihough v. Acclarent, Inc. et al here: https://www.pacermonitor.com/public/case/58108123/Fernihough_v_Acclarent,_Inc_et_al. Timeline note: The date of this incident ID is 05/19/2023; reporting generally arose in February 2026. The incident ID was created 06/09/2026. See also Incident 1436.
Entities
View all entitiesAlleged: Integra LifeSciences , AI-enabled surgical navigation system developers , AI-enabled healthcare system developers and Acclarent developed an AI system deployed by Surgical teams using TruDi Navigation System and Marc Dean, which harmed Surgical patients , Patients undergoing AI-guided procedures , Patients , Donna Fernihough and Balloon sinuplasty patients.
Alleged implicated AI systems: TruPath , Machine-learning surgical planning systems , Balloon sinuplasty navigation systems , AI-enabled surgical navigation systems , AI-enabled healthcare systems and Acclarent TruDi Navigation System
Incident Stats
Incident ID
1528
Report Count
2
Incident Date
2023-05-19
Editors
Daniel Atherton
Incident Reports
Reports Timeline
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In 2021, a unit of healthcare giant Johnson & Johnson announced "a leap forward": It had added artificial intelligence to a medical device used to treat chronic sinusitis, an inflammation of the sinuses. Acclarent said the software for its …
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Artificial intelligence has taken the medical device industry by storm --- even adding a layer of complexity to the operating room that's resulting in patients being hurt, some health professionals claim.
As Reuters reports, the TruDi Navig…
Variants
A "variant" is an AI incident similar to a known case—it has the same causes, harms, and AI system. Instead of listing it separately, we group it under the first reported incident. Unlike other incidents, variants do not need to have been reported outside the AIID. Learn more from the research paper.
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