US EditionAs AI enters the operating room, reports arise of botched surgeries and misidentified body parts
Since 2021, FDA received over 100 malfunction reports on AI surgical devices and at least 10 injuries, raising concerns about safety and regulatory oversight.
- In 2021, Acclarent, a unit of Johnson & Johnson, added machine‑learning features to the TruDi Navigation System, which had been on the market for about three years, to assist ear, nose and throat specialists.
- With the number of AI devices surging, regulators and former FDA scientists say staffing losses in the Division of Imaging, Diagnostics and Software Reliability have overstretched reviewers.
- Reports and court documents describe at least 10 patients injured between late 2021 and November 2025, including Erin Ralph and Donna Fernihough, with lawsuits alleging TruDi's AI caused strokes and surgical errors.
- Integra LifeSciences said FDA reports only show TruDi was used and there is `no credible evidence` linking AI to injuries, while plaintiffs allege Acclarent lowered safety standards and Dr. Marc Dean received over $550,000 consulting fees, with at least $135,000 related to TruDi, per Open Payments.
- Reuters analysis found at least 1,401 reports filed to the FDA involve 1,357 AI devices, with at least 115 citing software or algorithm problems.
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11 Articles
AI in the operating room: Reports of botched surgeries, misidentified body parts rise | Honolulu Star-Advertiser
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.
As AI enters the operating room, reports arise of botched surgeries and misidentified body parts
Medical device makers have been rushing to add AI to their products. While proponents say the new technology will revolutionize medicine, regulators are receiving a rising number of claims of patient injuries.
Incidents linked to a device that allows surgeons to treat chronic sinusitis with artificial intelligence have raised concerns in the US. Can AI be a panacea?
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