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Entities

Patients undergoing AI-assisted procedures

Incidents Harmed By

Incident 14362 Report
AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

2022-06-23

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.

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Related Entities
Other entities that are related to the same incident. For example, if the developer of an incident is this entity but the deployer is another entity, they are marked as related entities.
 

Entity

Marc Dean

Incidents involved as Deployer
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

Surgical teams using TruDi Navigation System

Incidents involved as Deployer
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

Acclarent

Incidents involved as Developer
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

More
Entity

AI-enabled surgical navigation system developers

Incidents involved as Developer
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

AI-enabled healthcare system developers

Incidents involved as Developer
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

Johnson & Johnson

Incidents involved as Developer
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

Integra LifeSciences

Incidents involved as Developer
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

More
Entity

Erin Ralph

Incidents Harmed By
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

Surgical patients

Incidents Harmed By
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

Patients

Incidents Harmed By
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

Sinus surgery patients

Incidents Harmed By
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

TruPath

Incidents implicated systems
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

Acclarent TruDi Navigation System

Incidents implicated systems
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

More
Entity

AI-enabled surgical navigation systems

Incidents implicated systems
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

More
Entity

AI-enabled healthcare systems

Incidents implicated systems
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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Entity

Surgical navigation systems

Incidents implicated systems
  • Incident 1436
    2 Reports

    AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure

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