Olympus WA22066ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761051613), received between May 4, 2018 and Sep 20, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CURRENT LEAKAGE WAS FELT IN THE WORKING ELEMENT AND HEAT WAS FELT ON THE TELESCOPE DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE. THE CUSTOMER WAS USING A NON-OLYMPUS CAUTERY. POST SURGERY, THE PATIENT REPORTED URINARY INCONTINENCE AND DEVELOPED URETHRAL STRICTURES. ON (B)(6) 2024, THE PATIENT RECEIVED MEDICAL TREATMENT AND WAS PRESCRIBED WITH MEDICATION TO TREAT THE URINARY INCONTINENCE DUE TO THE STRICTURES. THERE WAS NO SURGICAL INTERVENTION. THE PATIENT HAS RECOVERED AND WAS DOING FINE IN HEALTH ASPECTS.

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 20268536 ↗
• InjuryJun 8, 2021Device Handling Problem; Device Handling Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE CONNECTION BETWEEN THE HANDLE AND THE ELECTRODE BROKE AND THE SUBJECT MEDICAL DEVICE BECAME UNUSABLE. AS A CONSEQUENCE, THE PROCEDURE WAS INTERRUPTED TO ORGANIZE A REPLACEMENT DEVICE FROM ANOTHER HOSPITAL. THE INTENDED PROCEDURE WAS THEN COMPLETED SUCCESSFULLY, BUT WITH A SIGNIFICANT DELAY IN PROCEDURE TIME. HOWEVER, THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957469 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE PATIENT'S BLADDER WAS PERFORATED. THE PHYSICIAN ASSUMED THAT THIS PERFORATION WAS CAUSED BY THE WORKING ELEMENT. NO FURTHER INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO REPORT OF MALFUNCTION FOR ANY OF THE MEDICAL DEVICES.

  Patient problems: Internal Organ Perforation

  MAUDE report 7486042 ↗