None 470066Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886874120293), received between Dec 2, 2025 and Sep 21, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Image Orientation Incorrect” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted surgical procedure, while targeting the customer found that the image angle shown by the 0 degree Endoscope did not match the horizon indicator shown on the system. The customer reseated the Endoscope and the issue was resolved. The procedure was completed with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: The customer did not observe any damage or missing screws on the Endoscope base. The Endoscope was not manually rotated prior to the issue. The endoscope will be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843379 ↗
• MalfunctionMar 30, 2026Output Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM ENDOSCOPE, 0° HAD A FAULT 45312 "LOSS OF THE RIGHT EYE". THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO FRAGMENTS FALL INTO THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736203 ↗
• MalfunctionFeb 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 0° ENDOSCOPE WAS FOUND TO BE BENT AT THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24385682 ↗
• MalfunctionJan 14, 2026Image Orientation Incorrect

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071756 ↗
• MalfunctionDec 2, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE FAILED NUMEROUS ATTEMPTS TO ENGAGE WITH THE ARM. THE CUSTOMER RESEATED THE DRAPE, TRIED A NEW DRAPE, REPROCESSED, AND ATTEMPTED TO USE A DIFFERENT ROBOT, BUT EACH TIME THE ENDOSCOPE FAILED TO ENGAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694690 ↗