Description: 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.
Editor Notes: See also Incident 1528. 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 , AI-enabled surgical navigation system developers , AI-enabled healthcare system developers , Johnson & Johnson and Integra LifeSciences developed an AI system deployed by Marc Dean and Surgical teams using TruDi Navigation System, which harmed Erin Ralph , Surgical patients , Patients , Patients undergoing AI-assisted procedures and Sinus surgery patients.
Alleged implicated AI systems: TruPath , Acclarent TruDi Navigation System , AI-enabled surgical navigation systems , AI-enabled healthcare systems and Surgical navigation systems
Incident Stats
Risk Subdomain
A further 23 subdomains create an accessible and understandable classification of hazards and harms associated with AI
7.3. Lack of capability or robustness
Risk Domain
The Domain Taxonomy of AI Risks classifies risks into seven AI risk domains: (1) Discrimination & toxicity, (2) Privacy & security, (3) Misinformation, (4) Malicious actors & misuse, (5) Human-computer interaction, (6) Socioeconomic & environmental harms, and (7) AI system safety, failures & limitations.
- AI system safety, failures, and limitations
Entity
Which, if any, entity is presented as the main cause of the risk
AI
Timing
The stage in the AI lifecycle at which the risk is presented as occurring
Post-deployment
Intent
Whether the risk is presented as occurring as an expected or unexpected outcome from pursuing a goal
Unintentional
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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