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	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the single use combination cleaning brush disintegrated.The issue occurred during reprocessing.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: b5, d8, and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.In the investigation, two potential lot numbers and two manufacturing dates have been found.The device was not returned to olympus for inspection, and the customer's reportable malfunction was not confirmed.Based on the results of the investigation the root cause could not be identified.The event can be [detected/prevented] by following the instructions for use which state: the instruction manual for bw-412t (drawing number gk1939, revision number 02) did not include any information regarding bristle loss from the brush.However, the instruction manual for the endoscope (cleaning, disinfection, and sterilization) (drawing number ge1016, revision number 11) contains the following descriptions: ¦ brushing the suction cylinder ¿when inserting the channel-opening cleaning brush into the suction cylinder, do not forcibly insert the brush beyond the middle of the brush section.Otherwise, the brush may become stuck in the suction cylinder.1.Insert the channel-opening cleaning brush into the suction cylinder as illustrated by c in figure 3.22, until half of the brush section is inserted.2.Turn the inserted brush once.3.Pull the brush out and clean the bristles with your fingertips in the detergent solution.4.Repeat until all debris is removed olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported the procedure was completed with the same equipment and without any delay.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19455184
• Report Number: 9614641-2024-01194
• Device Sequence Number: 8612171
• Product Code: MNL
• UDI-Device Identifier: 04953170297427
• UDI-Public: 04953170297427
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: CLASS1EXMPT
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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
• Device Lot Number: V2Y11 OR V2Y14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown