AI-Enhanced Surgical Device Linked to Patient Injuries in U.S. Hospitals
An AI-enhanced surgical navigation system designed to treat chronic sinusitis reportedly caused patient injuries including strokes and punctured brain tissue. Two patients sued Acclarent, claiming the device provided inaccurate positioning information to surgeons after AI integration, though Integra LifeSciences (which acquired Acclarent) denies any causal link to the AI.
What happened
Acclarent's TruDi Navigation System, an image-guided surgical device for treating chronic sinusitis, was on the market for three years with seven unconfirmed reports of malfunction. The company announced in 2021 that it would integrate AI to assist surgeons during sinus procedures.
Following the AI integration, the FDA received more than 100 notifications of device malfunctions and at least 10 reports of patient injuries. Injuries reportedly included a surgeon puncturing the base of a patient's skull, cerebrospinal fluid leaking from a patient's nose, and patients suffering strokes after the surgeon accidentally struck a major artery, with the AI system reportedly providing inaccurate information about instrument position inside the patient.
Reported impact
Two patients who suffered strokes during sinuplasties involving the TruDi Navigation System sued Acclarent (later acquired by Integra LifeSciences). Plaintiff Erin Ralph alleged the device misled surgeon Marc Dean during a 2022 procedure, causing injury to her carotid artery, a blood clot, and stroke. Plaintiff Donna Fernihough alleged her carotid artery ruptured during surgery, causing blood loss and stroke the same day.
Index analysis
The lawsuits allege that 'the product was arguably safer before integrating changes in the software to incorporate artificial intelligence than after the software modifications were implemented.' Fernihough's suit alleged Acclarent 'knew or should have known that the purported artificial intelligence caused or exacerbated the tendency of the integrated navigation system product to be inconsistent, inaccurate, and unreliable' and set 'as a goal only 80 percent accuracy for some of this new technology before integrating it into the TruDi Navigation System.'
Governance controls
Integra LifeSciences stated there is 'no credible evidence to show any causal connection between the TruDi Navigation System, AI technology, and any alleged injuries.' Acclarent denied allegations in both suits. The incidents remain under FDA review, and the agency has not attributed the injuries to AI.
Classification
Sources and evidence
This record was researched and written by the Index, based on the following original reporting.