AI Powered Medical Devices Leads to Spike in Surgery Mistakes

Botched surgeries are on the rise after medical companies crammed AI into their medical devices to enhance surgery procedures.

One of the things AI pushers have long been saying is that AI can do everything better than any silly human being can. So, according to them, it’s only a matter of time before companies just implement all that nice and wonderful AI so they can say “goodbye” to having to pay all those meatheads money to do the job.

For reasons that should be ridiculously obvious, that isn’t happening. We’ve seen predictions that everyone is going to be out of work by the end of 2024, 2025, and so on and, so far, those predictions have predictably not come true. So, the pushers of AI just keep moving the date all of this happens back further and further with the hopes that, this time, they’ll be correct. After all, according to them, AI is improving in insane ways every day and it will all eventually happen.

Meanwhile, in the real world, we have the joys of watching people honestly believe these people and end up getting burned by it. As a result, we have an endless supply of examples where people put their trust in AI and that decision blowing up in their faces. Examples of this include lawyers getting in trouble for fake AI inserted citations in legal briefs, the CNET scandal, the Gannet Scandal, bad “journalism” predictions, fake news stories, more fake stories, Google recommending people eating rocks, the 15% success rate story, bad chess tactics, the Chicago Sun-Times scandal, a Canadian team submitting fake legal citations in their legal briefs, other attorneys submitting fake citation filled legal documents, the 91% failure rate story, AI deleting user data, the lawyer who got fined $10,000 over a bogus AI written legal brief, AI killing workplace productivity with workslop, AI having an 81% failure rate in summarizing news content, AI Overview giving out bad health advice, AI only being able to successfully complete 2.5% of commission work successfully at best, AI slowing software development down by 19%, AI hallucinating in even more court documents, AI being bad at poker, and AI slop flooding the scientific community.

Yes, I just keep adding to that list as I find examples. The larger that list gets, the more fun it gets publishing it.

Now, one of the things that AI pushers say is that while generative AI is, in fact, bad at pretty much everything, the same cannot be said for other forms of AI. Whether it is AI that specifically helps with scientific research or medical sciences, those AIs are transforming everything to make things even better. Well, with respect to the medical field, even that view was recently dealt a blow. A new report came out suggesting that AI is actually not helping and, this time, you can’t blame Large Language Modules (LLMs) for it.

The report comes from Reuters and it points out that companies are cramming AI into medical devices and calling it an “upgrade”. Since those supposed “upgrades”, however, there has been a reported spiked in botched surgeries. Yeah, uh oh. From Reuters:

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.

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.

Yeah, that doesn’t sound good. Now, you might be wondering if there was also litigation since this seems like a prime situation for such a thing to happen within the US. Oh yeah, that’s a thing too:

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 incorporate artificial intelligence than after the software modifications were implemented,” one of the suits alleges.

Reuters could not independently verify the lawsuits’ allegations.

Asked about the FDA reports on the TruDi device, Johnson & Johnson referred questions to Integra LifeSciences, which in 2024 purchased Acclarent and the TruDi Navigation System. Integra LifeSciences said the reports “do nothing more than indicate that a TruDi system was in use in a surgery where an adverse event took place.” It added that “there is no credible evidence to show any causal connection between the TruDi Navigation System, AI technology, and any alleged injuries.”

Whether or not there is evidence linked to that system, that is apparently up to the courts to decide.

Now, I know what some might be thinking. Some might be thinking that this is all just a one off instance. Yeah, apparently, this is by no means a one off:

At least 1,357 medical devices using AI are now authorized by the FDA – double the number it had allowed through 2022. The TruDi system isn’t the only one to come under question: The FDA has received reports involving dozens of other AI-enhanced devices, including a heart monitor said to have overlooked abnormal heartbeats and an ultrasound device that allegedly misidentified fetal body parts.

Researchers from Johns Hopkins, Georgetown and Yale universities recently found that 60 FDA-authorized medical devices using AI were linked to 182 product recalls, according to a research letter published in the JAMA Health Forum in August. Their review showed that 43% of the recalls occurred less than a year after the devices were greenlighted. That’s about twice the recall rate of all devices authorized under similar FDA rules, the review noted.

Oh fun, so it’s basically an industry-wide problem. Yeah, something tells me that the next report about the “revolutionary” AI powered medical devices will conveniently leave this little doozy of a report out.

Still, no one likes the idea of their surgery getting botched. Even more terrifying is the prospect of the AI botching their surgery on top of it all. Now that AI is being crammed into medical devices, I suppose I shouldn’t be surprised AI is screwing those procedures up to. One more item to throw onto the evidence pile.

Drew Wilson on Mastodon, Twitter and Facebook.