Single-Site; daVinci Si 428115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886874112113), received between May 30, 2023 and May 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2023Unintended System Motion; Difficult to Open or Close; Unintended System Motion; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE WRIST NEEDLE DRIVER WAS FOUND TO HAVE THE TIP TIGHT, AND THE MOVEMENT WAS NOT SMOOTH WHEN MOVING. THE SAME INSTRUMENT WAS USED TO CONTINUE THE SURGERY. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON HAD A BACK-UP INSTRUMENT BUT WANTED TO CONVERT TO LAPAROSCOPIC SURGERY. THERE WAS NO OTHER REASON TO CONVERT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17028345 ↗