AI Incident Database: AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure
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.
AI Incident Database · Incident 1436Operator lens (high): inspect D2 (output validation), D4 (observability), D5 (model change gate).
Event summary
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.
Linked entities
- acclarent
organisation | 70%
- ai-enabled-surgical-navigation-system-developers
organisation | 70%
- ai-enabled-healthcare-system-developers
organisation | 70%
- johnson-and-johnson
organisation | 70%
- integra-lifesciences
organisation | 70%
- marc-dean
organisation | 70%
- surgical-teams-using-trudi-navigation-system
organisation | 70%
- erin-ralph
organisation | 70%
- surgical-patients
organisation | 70%
- patients
organisation | 70%
- patients-undergoing-ai-assisted-procedures
organisation | 70%
- sinus-surgery-patients
organisation | 70%
Related graph edges
| Edge | Type | Confidence |
|---|---|---|
| ent-aiid-acclarent to ent-psf-d2 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d2 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d2 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d4 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d4 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d4 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d5 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d5 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d5 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d6 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d6 | maps to | 60% |
| ent-aiid-acclarent to ent-psf-d6 | maps to | 60% |