Olympus WA69424MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761083669), received between Apr 17, 2025 and Apr 17, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Melted” (3 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.

• MalfunctionApr 17, 2025Melted; Sparking; Melted; Sparking

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859699 ↗
• MalfunctionApr 17, 2025Melted; Sparking; Melted; Sparking

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE USING THE SUBJECT DEVICE, WHEN OUTPUTTING IN A CLOSE STATE WITHOUT CONTACT WITH THE METAL OF THE MONOPOLAR MACHINE, SPARKS FLEW AND THE TIP OF THE SUBJECT DEVICE MELTED. THE THERAPEUTIC UTERINE MYOMECTOMY PROCEDURE WAS COMPLETED AFTER REPLACEMENT WITH A SIMILAR OLYMPUS BACK UP NEW DEVICE. THE PATIENT WAS UNDER SEDATION WITH DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS PROLONGED FOR ONLY A FEW MINUTES FOR THE REPLACEMENT OF THE DEVICE. PER ADDITIONAL INFORMATION MALFUNCTION OCCURRED ONLY DURING CUTTING OUTPUT, DID NOT OCCUR DURING COAG-OUTPUT. THERE WAS NO HEALTH HAZARD TO THE PATIENT OR THE DEVICE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858938 ↗
• MalfunctionApr 17, 2025Melted; Sparking; Melted; Sparking

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857537 ↗