Gyrus ACMI UBP-SETRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925038837), received between Aug 2, 2022 and Feb 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood 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.

• MalfunctionFeb 15, 2023Leak/Splash; Leak/Splash

  THE OLYMPUS SALES REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THERE WAS A LEAK ON THE BIOPSY PORT SEAL (6-PER). THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE (URETEROSCOPY), THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378078 ↗
• MalfunctionAug 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED TO OLYMPUS THAT UPON INITIAL USE OF THE DEVICE, IT LEAKED DURING A DEMONSTRATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153524 ↗