MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE COMBINATION CLEANING BRUSH; SINGLE USE SINGLE-ENDED CLEANING BRUSH

Model Number	BW-412T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported during reprocessing, nurse found brush stuck in biopsy channel.There were no report of patient involvement.----------------------------------------------- 05-aug-2025, we received following information from dd-122862: 1.With reference to the event description mentions another device, the ¿brush stuck in biopsy channel¿ could you kindly confirm whether the brush is an olympus product? if yes, we would appreciate it if you could provide the product model, serial number, and item code for our reference.Answer: olympus, bw-412t.2.Could you please kindly confirm was there any malfunction of product ¿brush¿? answer: brush separate from the body and struct inside the scope.3.Could you please kindly confirm whether the product referred to as ¿brush¿ will be returned to olympus? if yes, we would appreciate it if you could also provide the return date, or the expected return date from the customer.Answer: cannot return.Customer already disposed.Remark: 1.This inquiry is a clone of parent inquiry inq-516979 (product #1: gif-ez1500 sn: (b)(6).This inquiry captures product #2: bw-412t.2.Lot/serial number and item code are/is unknown as related information was not mentioned in the original inquiry.
Additional Manufacturer Narrative
Updated fields: h2, h3, h6, and h11.This supplemental report is being submitted to provide the results of the final investigation.The device was not returned to olympus for inspection and the reported failure was not confirmed.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.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
No additional information received from customer.

• Brand Name: SINGLE USE COMBINATION CLEANING BRUSH
• Common Device Name: SINGLE USE SINGLE-ENDED CLEANING BRUSH
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22906075
• Report Number: 9614641-2025-01441
• Device Sequence Number: 8931916
• Product Code: MNL
• UDI-Device Identifier: 04953170297427
• UDI-Public: 04953170297427
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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-412T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown