Olympus A3661Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761005432), received between Apr 4, 2022 and Apr 4, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2022Material Deformation; Material Deformation

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE THE CERAMIC INSULATIONS AT THE DISTAL END OF TWO RESECTION SHEATHS BROKE OFF ONE AFTER THE OTHER AND FRAGMENTS FELL INTO THE PATIENT'S BLADDER. PRESUMABLY, THIS MAY HAVE BEEN CAUSED BY THE PUNCH FOR BLADDER STONES USED DURING THE PROCEDURE, WHICH ALLEGEDLY WAS SLIGHTLY DEFORMED AT ITS DISTAL END. NO FRAGMENTS REMAINED INSIDE THE PATIENT SINCE THEY WERE REPORTEDLY BROKEN INTO SMALLER PIECES AND THEN FLUSHED OUT USING AN ELLIK EVACUATOR. THIS CAUSED A CERTAIN DELAY TO THE PROCEDURE, WHICH HOWEVER, WAS NOT CONSIDERED MEDICALLY RELEVANT FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY. THIS INCIDENT HAS ALREADY BEEN REPORTED WITH MFR REPORT # 9610773 - 2022 - 00120 AND MFR REPORT # 9610773 - 2022 - 00121 SUBMITTED FOR THE TWO OLYMPUS RESECTION SHEATHS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994565 ↗