None 430075Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886874119556), received between Aug 29, 2025 and Feb 19, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 15, 2025Open, Classified

   Access Port System tray may develop cracks potentially resulting in a sterility breach.

   Z-1096-2026 · Root cause: Packaging change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE PORT CHAMBER OF THE ACCESS PORT KIT WAS BROKEN. THE PROCEDURE WAS COMPLETED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE DAMAGE WAS AROUND THE BLUE ASSISTANT PORT. THERE WAS AIR LEAKAGE DUE TO A BROKEN PORT CHAMBER. THE REPORTER STATED THAT THIS RESULTED IN A SUDDEN LOSS OF INSUFFLATION. THE SUDDEN LOSS OF INSUFFLATION DID NOT PRESENT ANY ISSUES OR CHALLENGES FOR THE PATIENT. IT WAS CONFIRMED THAT THE DAMAGED PART WAS NOT BROKEN OFF OR DETACHED FROM THE ACCESS PORT KIT DURING THE EVENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393134 ↗
• MalfunctionSep 10, 2025Gas/Air Leak; Gas/Air Leak

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019661 ↗
• MalfunctionSep 2, 2025Gas/Air Leak; Gas/Air Leak

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945133 ↗
• MalfunctionAug 29, 2025Detachment of Device or Device Component; Gas/Air Leak; Detachment of Device or Device Component; Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE TRANSVESICAL PROSTATECTOMY SURGICAL PROCEDURE, THE METAL RING OF THE SINGLE-PORT (SP) ACCESS PORT KIT BECAME LOOSE. THERE WAS NO COLLISION WITH ANY INSTRUMENTS. THE CUSTOMER USED ANOTHER SP ACCESS PORT KIT TO RESOLVE THE ISSUE. 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: THERE WAS A SUDDEN LOSS OF INSUFFLATION IN THE EXTRAPERITONEAL SPACE. THE RING WAS A METAL OR SILVER COLOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929508 ↗