"Artificial intelligence has taken the medical device industry by storm - even adding a layer of complexity to the operating room that's resulting in patients being hurt, some health professionals claim. As Reuters reports, the TruDi Navigation System by device maker Acclarent was designed to treat chronic sinusitis, inflammation of the nasal sinuses, by inserting a tiny balloon to enlarge the sinus cavity openings."
"But ever since the company added AI to the device, the US Food and Drug Administration has received at least unconfirmed 100 reports of malfunctions and adverse events, including at least ten instances of patients being injured. While it's still unclear what role AI played in these instances, the resulting injuries can be grim, from the punctured base of a patient's skull to cerebrospinal fluid leaking from one another's nose, per the reports."
AI was integrated into the TruDi Navigation System, a device for treating chronic sinusitis by inserting a balloon to enlarge sinus openings. After the AI update, the FDA received about 100 unconfirmed reports of malfunctions and adverse events, including at least ten patient injuries. Reported harms include punctured skull base, cerebrospinal fluid leaks, and reported strokes following sinuplasty procedures. Two patients filed lawsuits alleging the device misled surgeons and caused carotid artery injuries leading to strokes. Plaintiffs allege the product was safer before AI changes. Acclarent, the device maker, has been acquired by Integra LifeSciences. The role of AI in these events remains unclear.
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