Risks of Using AI in Surgery: FDA Receives Over 1,400 Reports of Problems

As the use of artificial intelligence in medical devices expands, the number of reports of medical errors linked to such technologies is increasing, Reuters writes.

Acclarent’s TruDi system, equipped with machine-learning AI, is used in otolaryngological surgery for three-dimensional visualization of the sinuses and for calculating optimal instrument pathways. With the help of TruSeg and TruPath, the AI automatically segments anatomical structures and assists during balloon sinuplasty procedures.

From late 2021 through November 2025, at least 10 cases of patient injuries were recorded that were attributed to physician errors caused by incorrect data from TruDi. Reported incidents include damage to major arteries and a case of accidental skull perforation resulting in cerebrospinal fluid leakage. In Texas, two individuals have filed lawsuits over the use of AI in the system.

Integra LifeSciences, which owns Acclarent, states that there is no evidence of a direct link between the AI system and the injuries. The FDA cautions that its reports do not always make it possible to definitively determine the cause of an incident.

From 2021 through October 2025, the FDA received more than 1,400 reports of issues involving AI-enabled medical devices. In 115 cases, problems with software or algorithms were cited, such as incorrect identification of fetal body parts during prenatal ultrasound examinations.

The regulator is facing difficulties due to a reduction in AI specialists: after Donald Trump returned to the White House in 2025, the relevant group was disbanded and some staff members left. New AI-enabled devices are not required to undergo patient trials, which experts believe increases risks.

Alexander Everhart, a lecturer at the University of Washington, notes that manufacturers often register new devices as updates to existing ones. In his view, the FDA’s traditional approach to regulating medical devices does not fully ensure the safety of AI technologies.

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