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Health·P Space·Evidence-backed problem·Published 2026-07-19

Davinci xi: FDA injury report involving AI

The FDA received a injury report involving Davinci xi, made by Intuitive surgical, inc. A review of a clinical literature article titled "usefulness of artificial intelligence for surgical support in robot-assisted distal pancreatectomy: a preliminary case report" was conducted. the article reported an event involving a da vinci-assisted distal pancreatectomy where the dissection line on the lower margin of the pancreas was falsely recognized and pancreatic tissue was damaged. the estimated blood loss…

TRV-2026-0271Official statisticsPermanent record — cite & verify
Davinci xi: FDA injury report involving AI

Col. Lovette receives 81st MDG immersion tour 170616-F-BD983-500 by Kemberly Groue. Public domain

The quick read

On 2026-06-23, an FDA device event record for Davinci xi by Intuitive surgical, inc. cited a literature case report on AI for surgical support in robot-assisted distal pancreatectomy. The record states the dissection line on the lower margin of the pancreas was falsely recognized and pancreatic tissue was damaged during the procedure.

The report matters because it documents a patient-level injury linked to AI guidance in robotic surgery, raising questions about validation and oversight of AI overlays in the operating room. The truncated record does not establish causality, incidence, or long-term outcome, and further investigation would be needed to determine system performance and contributing factors.

Main points
  • FDA MAUDE report 25596952 documents an injury involving Davinci xi made by Intuitive surgical, inc.
  • The report references literature titled "usefulness of artificial intelligence for surgical support in robot-assisted distal pancreatectomy: a preliminary case report".
  • In the reported da vinci-assisted distal pancreatectomy, AI support falsely recognized the dissection line on the lower margin of the pancreas.
Problem

AI support for robot-assisted distal pancreatectomy falsely recognized the dissection line, resulting in pancreatic tissue damage reported to FDA.

The rundown

The source is FDA MAUDE report 25596952 dated 2026-06-23, describing a review of a clinical literature article on AI for surgical support in robot-assisted distal pancreatectomy.

The event involved a da vinci-assisted distal pancreatectomy where the AI misidentified the lower pancreatic margin dissection line, leading to tissue damage and noted estimated blood loss.

Sources

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