AI incident ·
AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty
On this page 6 sections
In brief
An AI system built by Integra Lifesciences, Ai Enabled Surgical Navigation System Developers and 2 others and deployed by Surgical Teams Using Trudi Navigation System and Marc Dean allegedly harmed Surgical Patients, Patients Undergoing Ai Guided Procedures and 3 others.
- Risk domain
- Not classified
- Occurred
- Coverage
- 2 reports
What happened
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.
Laws on record for this risk area
No instrument on record yet covers this risk area where it happened. See the open queue.
Matched from the record's risk category and country to the instruments in effect recorded here: a law listed covers the area, which is not a finding that it applies to this incident. A reviewer can correct the match in the repository (data/external/incident_overrides.yaml).
News reports (2)
Titles link to the original publisher; report text is not reproduced here.
Who was involved
- Alleged deployer
- Surgical Teams Using Trudi Navigation System, Marc Dean
- Alleged developer
- Integra Lifesciences, Ai Enabled Surgical Navigation System Developers, Ai Enabled Healthcare System Developers, Acclarent
- Alleged harmed party
- Surgical Patients, Patients Undergoing Ai Guided Procedures, Patients, Donna Fernihough, Balloon Sinuplasty Patients
Classification (MIT AI Risk Repository taxonomy)
- Risk domain
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- Risk subdomain
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- Causal entity
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- Intent
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- Timing
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- Harm level
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- Sectors
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Source record: incident #1528 on the AI Incident Database · all 2 reports