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https://www.productionai.institute/graph/events/evt-aiid-1528

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Production AI Institute public record · AI Incident Database: AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty · observed 2026-06-09
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AI Incident Database: AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty

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.

AI Incident Database · Incident 1528

Operator lens (high): inspect D2 (output validation), D4 (observability), D5 (model change gate).

Confidence
82%
Sources
3
Entities
11
Detected
detected 38d ago

Event summary

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.

D2D4D5D6

Linked entities

  • integra-lifesciences

    organisation | 70%

  • ai-enabled-surgical-navigation-system-developers

    organisation | 70%

  • ai-enabled-healthcare-system-developers

    organisation | 70%

  • acclarent

    organisation | 70%

  • surgical-teams-using-trudi-navigation-system

    organisation | 70%

  • marc-dean

    organisation | 70%

  • surgical-patients

    organisation | 70%

  • patients-undergoing-ai-guided-procedures

    organisation | 70%

  • patients

    organisation | 70%

  • donna-fernihough

    organisation | 70%

  • balloon-sinuplasty-patients

    organisation | 70%

Related graph edges

EdgeTypeConfidence
ent-aiid-acclarent to ent-psf-d2maps to60%
ent-aiid-acclarent to ent-psf-d2maps to60%
ent-aiid-acclarent to ent-psf-d2maps to60%
ent-aiid-acclarent to ent-psf-d4maps to60%
ent-aiid-acclarent to ent-psf-d4maps to60%
ent-aiid-acclarent to ent-psf-d4maps to60%
ent-aiid-acclarent to ent-psf-d5maps to60%
ent-aiid-acclarent to ent-psf-d5maps to60%
ent-aiid-acclarent to ent-psf-d5maps to60%
ent-aiid-acclarent to ent-psf-d6maps to60%
ent-aiid-acclarent to ent-psf-d6maps to60%
ent-aiid-acclarent to ent-psf-d6maps to60%

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Event dates

  • Happened 19 May 2023

  • Detected 9 June 2026

Sources

  • AI Incident Database - Incident 1528

    secondary | checked 9 July 2026

    Open source
  • AI-Powered Surgery Tool Repeatedly Injuring Patients, Lawsuits Claim

    secondary | checked 9 June 2026

    Open source
  • As AI enters the operating room, reports arise of botched surgeries and misidentified body parts

    primary | checked 9 Feb 2026

    Open source
Cite this record

"AI Incident Database: AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty." https://www.productionai.institute/graph/events/evt-aiid-1528 (observed 2023-05-19; retrieved 2026-07-17). PAI.

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