N/A 05-0761nirRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250480109045), received between Sep 8, 2026 and Sep 9, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Temperature Problem

  It was reported that during a da Vinci-assisted unilateral inguinal hernia surgical procedure, the customer contacted Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) to report that the light box and handheld camera, which had been powered off, unexpectedly powered itself on and burned a hole in the drape. The customer indicated that the light box and handheld camera would not be used until the equipment had been inspected. The procedure was completed with no reported injury.ISI followed up with the Nurse and obtained the following additional information: The Light Guide Cable issue did not cause any thermal injury to the Operating Room (OR) staff.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50688018 ↗
• MalfunctionSep 8, 2026Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680615 ↗