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# Issues with AI-Enhanced Surgical Devices Cited
- URL: https://www.fdaweb.com/issues-with-ai-enhanced-surgical-devices-cited/
- Published: 2026-02-11T12:00:00.000Z
- Updated: 2026-09-14T13:33:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160654

A detailed report published by the Reuters news service says FDA is receiving an increasing number of complaints about patient injuries during surgeries involving medical devices that use artificial intelligence (AI). Much of the [report](https://www.reuters.com/investigations/ai-enters-operating-room-reports-arise-botched-surgeries-misidentified-body-2026-02-09/?ref=fdaweb.com) (paywall) discusses the Acclarent TruDI navigation system that is used to show doctors where their instruments are inside patients’ heads during chronic sinusitis surgery. “Since AI was added to the device,” Reuters says, “FDA has received unconfirmed reports of at least 100 malfunctions and adverse events…. 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.”

Integra Lifesciences, which purchased Acclarent and the system in 2024, said the reports only indicate that the system was being used in a surgery where an adverse event took place, and there is “no credible evidence to show any causal connection between the TruDi Navigation System, AI technology, and any alleged injuries.”

The report says that at least 1,357 medical devices using AI are now authorized by FDA, double the number it has allowed through 2022\. “The AI boom poses a problem for FDA, five current and former agency scientists told Reuters,” it says. “The agency is struggling to keep pace with the flood of AI-enhanced medical devices seeking approval after losing key staff.”

After discussing several other examples of adverse events involving different medical devices, the report looks at how staffing cuts under the Trump administration are affecting the agency’s ability to respond.

It notes that about 15 of the 40 AI scientists who were in CDRH’s Division of Imaging, Diagnostics, and Software Reliability were laid off or opted to leave. Likewise, the Digital Health Center of Excellence lost about one-third of its complement.

HHS spokesman **Andrew Nixon** told the news service that FDA is applying the same rigorous standards to medical devices aided by machine learning and other AI as it would to any product.