Single Use Single-ended Cleaning Brush BW-400LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170297984), received between Aug 30, 2023 and Aug 30, 2023 — classified as 1 malfunction.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS AN ISSUE WITH THE SINGLE USE SINGLE-ENDED CLEANING BRUSH; CANNOT INSERT OR REMOVE THE BRUSH FROM THE BALLOON CHANNEL. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.THE DEVICE WAS RETURNED TO OLYMPUS FOR A DEVICE EVALUATION AND FOUND THE SINGLE USE SINGLE-ENDED CLEANING BRUSH HAD BEEN DAMAGED/BROKEN AND REMAINED IN THE CHANNEL OF THE SCOPE. NO PATIENT OR PROCEDURE WAS INVOLVED WITH THIS EVENT.THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647771 ↗