Cleaning brush MAJ-1534Recalls & reported problems
Olympus Medical Systems Corp. · MAJ-1534 CLEANING BRUSH · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170208485), received between Aug 3, 2023 and Aug 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Reprocessing 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Reprocessing Problem1
- Failure to Clean Adequately1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2023Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately
THE ENDOSCOPY SUPPORT SPECIALIST REPORTED TO OLYMPUS THAT THE CLEANING BRUSH THAT WAS USED DURING CLEANING OF THE LINEAR EUS SCOPES, WAS NOT RECOMMENDED BY OLYMPUS. THE FACILITY USED A PATIENT TOOTHBRUSH FOR CLEANING AND STATED THAT THEY MADE AN INFECTION PREVENTION DECISION TO MOVE AWAY FROM USING THE MAJ-1534 CLEANING BRUSH BECAUSE THEY DID NOT WANT TO USE ANY REUSABLE BRUSHES. THE REGISTERED NURSE WAS ADVISED THAT THE CLEANING STEPS WERE OUTSIDE OF THE INSTRUCTION FOR USE (IFU) FROM OLYMPUS. THE ISSUE WAS FOUND DURING A DEMONSTRATION AT AN IN-SERVICE VISIT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455217 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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