None 432701Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886874124598), received between Nov 5, 2025 and Sep 25, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898515 ↗
• InjuryAug 11, 2026Material Fragmentation

  It was reported that during a da Vinci-assisted surgical procedure, the Advanced Access Port Kit accessory piece broke off. A fragment fell into the patient and was successfully retrieved during the same procedure. The procedure was completed as planned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50207554 ↗
• MalfunctionNov 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER DID NOT INSTALL THE 12-6 MM REDUCER AFTER SWAPPING FROM A SUREFORM STAPLER TO A 6 MM INSTRUMENT. INSERTING THE 6 MM INSTRUMENT WITHOUT THE REDUCER LED TO A LOSS OF INSUFFLATION, CAUSING THE AIRSEAL INSUFFLATOR TO STOP AND RESULTING IN A LOSS OF SURGICAL WORKSPACE. THE CUSTOMER TOOK A FEW MINUTES TO TROUBLESHOOT BEFORE IDENTIFYING THE MISSING REDUCER AS THE CAUSE OF THE PROBLEM, DURING WHICH THE SURGEON OPERATED WITH A RESTRICTED WORKSPACE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480006 ↗