Medical device company Acclarent added artificial intelligence to its TruDi Navigation System to assist doctors with sinus surgery. A Twitter post by the company in October 2021 introduced the new AI features.
Posted on 02/09/2026 3:03:35 PM PST by E. Pluribus Unum
In 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence to a medical device used to treat chronic sinusitis, an inflammation of the sinuses. Acclarent said the software for its TruDi Navigation System would now use a machine-learning algorithm to assist ear, nose and throat specialists in surgeries.
The device had already been on the market for about three years. Until then, the U.S. Food and Drug Administration had received unconfirmed reports of seven instances in which the device malfunctioned and another report of a patient injury. Since AI was added to the device, the FDA has received unconfirmed reports of at least 100 malfunctions and adverse events.
Medical device company Acclarent added artificial intelligence to its TruDi Navigation System to assist doctors with sinus surgery. A Twitter post by the company in October 2021 introduced the new AI features.
At least 10 people were injured between late 2021 and November 2025, according to the reports. Most allegedly involved errors in which the TruDi Navigation System misinformed surgeons about the location of their instruments while they were using them inside patients’ heads during operations.
Cerebrospinal fluid reportedly leaked from one patient’s nose. In another reported case, a surgeon mistakenly punctured the base of a patient’s skull. In two other cases, patients each allegedly suffered strokes after a major artery was accidentally injured.
FDA device reports may be incomplete and aren’t intended to determine causes of medical mishaps, so it’s not clear what role AI may have played in these events. The two stroke victims each filed a lawsuit in Texas alleging that the TruDi system’s AI contributed to their injuries. “The product was arguably safer before integrating changes in the software to...
(Excerpt) Read more at reuters.com ...
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That doesn't sound good.
Cerebrospinal fluid reportedly leaked from one patient’s nose.
That doesn’t sound good.
+++++++++++++++++++++++++++++
I am not a doctor, but yeah that is way not good.
Everyone should refuse J&J’s AI surgeon until the CEO allows it to perform a vasectomy on him ...
Would that would be micro surgery ?
GenAI hallucinates.
Isn’t that special?
How does this compare with human surgeons records?
Dam right
Dr. AI: This patient has five fingers. He needs one added.
Savana Guthrie has 6 finners
There are always problems in the beginning but I bet in five years there won’t be a difference and in ten you will be asking yourself why you would want a human surgeon when a robot doesn’t make mistakes.
Do you have proof that "a robot doesn’t make mistakes?"
Yeah...that seems a reasonable question...
“FDA device reports may be incomplete and aren’t intended to determine causes of medical mishaps, so it’s not clear what role AI may have played in these events.”
In ten years, E.
I wont allow Muslim doctors work on me because of the taqiyah and silent Jihad issues,
Just sayin'.
In ten years AI will be omniscient, b?
When should we hold our weekly worship services?
5 years ago in AI was nearly eternity.
That’s when the device got AI.
This article is not relevant any longer.
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