None 400077Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886874110997), received between Jan 12, 2023 and Dec 4, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Gas/Air Leak; Gas/Air Leak

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720817 ↗
• MalfunctionJan 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CANNULA SEAL HAD A LEAKAGE AND COULD NOT CONTAIN THE GAS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY AND LESS THAN A 15-MINUTE DELAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS RAPID LOSS OF INSUFFLATION. NO BROKEN PIECES WERE FOUND ON THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072020 ↗
• MalfunctionSep 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AT THE TIME AN INSTRUMENT WAS INSTALLED, THE SITE OBSERVED A BROKEN VALVE IN THE CANNULA SEAL AND AN ALLEGED AIR LEAK OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338335 ↗
• MalfunctionSep 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AT THE TIME AN INSTRUMENT WAS INSTALLED, THE SITE OBSERVED A BROKEN VALVE IN THE CANNULA SEAL AND AN ALLEGED AIR LEAK OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338062 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, PIECES FROM THE CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE ALL FRAGMENTS DURING THE SAME PROCEDURE. THE CUSTOMER REPLACED THE CANNULA SEAL WITH A BACK-UP ACCESSORY OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928119 ↗
• InjuryJan 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN UNKNOWN FRAGMENT WAS FOUND INSIDE THE PATIENT'S ANATOMY AND RETRIEVED IMMEDIATELY UPON BEING SEEN. IT WAS FOUND THAT THE UNKNOWN FRAGMENT WAS PART OF THE SILICON FOR THE 8MM CANNULA SEAL. THE PROCEDURE WAS COMPLETED USING A BACKUP CANNULA SEAL WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT OF THE CANNULA SEAL WAS RETRIEVED DURING THE SAME PROCEDURE. IT WAS CONFIRMED VISUALLY THAT ALL THE FRAGMENTS WERE REMOVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TESTS PERFORMED REGARDING THE REMOVED FRAGMENT. IT WAS UNKNOWN HOW LONG THE CANNULA SEAL WAS IN USE FOR PRIOR TO THE ISSUE, AND THE SURGEON DOES NOT KNOW WHAT THE CAUSE COULD HAVE BEEN. THE CANNULA SEAL WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. THE SURGEON DID NOT NOTICE ANY FUNCTIONALITY ISSUES. THE SURGEON DID NOT KNOW EXACTLY HOW THE FRAGMENT FELL INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16144997 ↗