Olympus WA90001ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761082952), received between Mar 1, 2021 and Nov 18, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Output Problem” (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 18, 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.

• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TURBINECTOMY PROCEDURE AT AN UNKNOWN DATE THE ESG-200 HF GENERATOR ISSUED MESSAGE E0689 (INSTRUMENT WEAROUT NOTE: THE INSTRUMENT IS ABOUT TO REACH ITS MAXIMUM USAGE TIME. REPLACE THE INSTRUMENT IF POSSIBLE). THE OLYMPUS BIPOLAR APPLICATOR "CELONPROBREATH" (WB990007), WHICH WAS USED DURING THE PROCEDURE IS NOT MARKETED IN THE US. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. DURING A POST-OPERATIVE EXAMINATION A FEW DAYS LATER, SCABS WERE OBSERVED IN THE PATIENT. SINCE THE SCABS HAVE BECOME INFECTED, THE PATIENT IS BEING TREATED WITH ANTIBIOTICS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection

  MAUDE report 15823952 ↗
• InjuryMay 16, 2022Output Problem; Activation Problem; Output Problem; Activation Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC PROCEDURE TO TREAT HYPERTROPHIC TURBINATES, THE HF-GENERATOR ESG-200 COULD NOT BE ACTIVATED. THE PATIENT HAD ALREADY BEING ANESTHETIZED WHEN THE DEVICE FAILURE WAS NOTICED RESULTING IN THE PROCEDURE BEING CANCELLED AS THE ISSUE COULD NOT BE RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14407000 ↗
• InjuryMar 1, 2021Output Problem; Output Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE AT AN UNKNOWN DATE THE PATIENT SUSTAINED A PERFORATION OF THE PALATE. THE SURGEON FELT THAT THE ISSUE WAS CAUSED BY THE GENERATOR¿S OUTPUT BEING TOO STRONG. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 11391508 ↗