MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CHANNEL CLEANING BRUSH

Model Number	BW-20T
Medical Device Problem Codes	Break (1069); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was not confirmed.A root cause could not be identified.Based on the results of the investigation: based on the description in source evaluation summary, loosening, stretching, bending of spiral tube at the brush head of cleaning brush which can be thought that caused the occurrence of phenomenon could confirmed.Based on the description in source evaluation summary, phenomenon of material failure was not confirmed, and it is presumed that the phenomenon occurred because cleaning brush was caught when withdrawing, and excessive force was applied.Based on the information obtained from this complaint and the investigation results, the cause of applied external excessive force was not identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device evaluation, the channel cleaning brush exhibited spiral tube at the tip of the cleaning brush is loose and bent, had multiple bending and residual dirt was confirmed.There was no patient involvement.

• Brand Name: CHANNEL CLEANING BRUSH
• Common Device Name: CLEANING BRUSH
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24791180
• Report Number: 3002808148-2026-09804
• Device Sequence Number: 21264306
• Product Code: MNL
• UDI-Device Identifier: 04953170022630
• UDI-Public: 04953170022630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: BW-20T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown