Description: During a reported sinus procedure in Texas, Acclarent's AI-enabled TruDi Navigation System was alleged to have misinformed surgeon Marc Dean about the position of his instruments inside patient Erin Ralph's head, purportedly contributing to carotid-artery injury and a stroke. Reuters reported that Ralph later sued, alleging the system's AI contributed to her injuries. Acclarent and Integra denied a causal connection.
Editor Notes: Timeline notes: (1) 10/2021, Acclarent publicly announced that AI had been added to the TruDi Navigation System. (2) 06/23/2022, the docket-derived date of Erin Ralph's sinuplasty procedure; Reuters reports the surgery occurred in June 2022, while a public filing snippet tied to the Ralph case specifies June 23, 2022 (p. 3 of https://www.docketalarm.com/cases/Texas_State_Dallas_County_134th_District_Court/DC-24-08801/ERIN_RALPH_vs._ACCLARENT_INC.et_al/01-27-25-Motion_Compel/1-PLAINTIFF_MOTION_TO_COMPEL_DISCOVERY_FROM_NONPARTY_MARC_DEAN_MD/). (3) 02/09/2026, the date Reuters publicly reported Ralph's allegations that the AI-enabled TruDi system contributed to her injuries. (4) 03/28/2026, incident ID created.
Entities
View all entitiesAlleged: Acclarent developed an AI system deployed by Marc Dean, which harmed Erin Ralph.
Alleged implicated AI systems: TruPath and Acclarent TruDi Navigation System
Incident Stats
Incident ID
1436
Report Count
1
Incident Date
2022-06-23
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 …
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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