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

Model Number	BW-20T
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 full name and address: (b)(6).Section d: device - the exact model of the brush is unknown, however, the customer uses bw-20t.When the scope was returned for inspection, the brush was not found inside the channel or returned with the scope.Additionally, during inspection of the scope, a cleaning brush was passed through the channel multiple times.Therefore, the customer allegation of the cleaning brush remaining in the channel could not be confirmed.Based on the results of the investigation, a root cause was unable to be 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 reported that the head of the cleaning brush was left in the biopsy channel.This was observed during inspection for use.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; nishishirakawa-gun, fukushima ; JA
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23934040
• Report Number: 3002808148-2025-27006
• Device Sequence Number: 9473606
• Product Code: MNL
• UDI-Device Identifier: 04953170022630
• UDI-Public: 04953170022630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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: Health Professional
• Device Model Number: BW-20T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CF-H290I
• Patient Sex: Unknown