Olympus A0355Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761001533), received between Nov 22, 2021 and Aug 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionAug 30, 2023Sparking; Sparking

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER DURING A THERAPEUTIC PROCEDURE HF-CABLE, MONOPOLAR WAS CONNECTED TO ST10 AND IT SPARKED AND DISCONNECTED. THE DEVICE WAS REPLACED WITH A SIMILAR ONE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650265 ↗
• MalfunctionNov 22, 2021Break; Break

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE HF CABLE BROKE A FEW CENTIMETERS FROM THE INSTRUMENT SIDE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851007 ↗