aceDavinci 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…
AI support for robot-assisted distal pancreatectomy falsely recognized the dissection line, resulting in pancreatic tissue damage reported to FDA.
Evidence
- GovernmentFDA MAUDE report 255969522026-06-23
How should this claim be treated?
Truvace Impact Record TRV-2026-0271, v1: “Davinci xi: FDA injury report involving AI.” Truvace, 2026-07-19. /record/TRV-2026-0271 (accessed at citation time). sha256 457a876d9a7df06b…
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