Olympus WA2UR12ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761086394), received between Mar 9, 2023 and Nov 17, 2025 — classified as 3 malfunctions.

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

• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT THE URETEROSCOPE WAS BROKEN OFF. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569174 ↗
• MalfunctionMay 23, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SHEATHING TUBE OF THE URETEROSCOPE HAD BROKEN DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985404 ↗
• MalfunctionMar 9, 2023Fitting Problem; Fitting Problem

  THE CUSTOMER¿S OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE LUER LOCK WOULD NOT FIT ON THE URETEROSCOPE. THE LUER LOCK WAS ATTEMPTED ON OTHER SCOPES AND IT WORKED. MULTIPLE LUER LOCKS WERE ATTEMPTED ON THE SUBJECT DEVICE AND NONE OF LUER LOCKS WORKED. THE OLYMPUS REPRESENTATIVE REPORTED THAT THERE MIGHT BE DAMAGE TO THE CONNECTOR FOR THE LUER LOCK. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519286 ↗