None 470551Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874120699), received between Mar 26, 2026 and May 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 11, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A NOTIFICATION APPEARED STATING THAT THE TOWER TOUCHSCREEN WAS NOT FUNCTIONING. THE FILTER FUNCTION ALSO DID NOT WORK WHEN USING ENERGY, MAKING IT DIFFICULT TO MAINTAIN VISIBILITY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS RESOLVED WITH BACKUP INSUFFLATOR SMOKE EVACUATION. THE PROCEDURE WAS COMPLETED AS PLANNED. THEY DID NOT USE AN EXTERNAL SUCTION DEVICE INSTEAD OF THE INSUFFLATOR SMOKE EVACUATION. THE ISSUE OCCURRED WHEN THE SMOKE EVACUATION FUNCTION WAS TURNED ON AFTER DOCKING. THE TOUCHSCREEN WAS NOT FUNCTIONING. THE ISSUE HAS NOT RECURRED SINCE THE REPORTED EVENT. THE INSUFFLATION TUBESET WAS INSPECTED WITH NO DAMAGE OBSERVED. THERE WAS NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143189 ↗
• MalfunctionMar 26, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ABDOMINAL PRESSURE SUDDENLY DROPPED TO ZERO DURING SURGERY AND COULD NOT BE INCREASED. AFTER THAT THE PRESSURE WAS SET TO THE SET PRESSURE AND KEPT IT. THE TECHNICAL SUPPORT ENGINEER (TSE) ADVISED CHECKING THE HOSES, CONNECTORS AND SETTINGS. THEN, THEY FOUND THE ISSUE OCCURRED WHEN A SURGEON WAS USING A VACUUM MACHINE. THE TSE EXPLAINED THAT WAS THE MOST LIKELY CAUSE, SO ADVISED ADJUSTING THE FLOW RATE OR SET PRESSURE HIGHER. AFTER THE FIRST CALL, THE ISSUE STILL PERSISTED, SO THEY REPLACED THE TUBE SET AND THEN THE ISSUE WAS COMPLETELY RESOLVED. THE TSE ADVISED TO RETURN THE ORIGINAL ONE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706784 ↗