MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. MLA-BW-400B; SINGLE-ENDED CLEANING BRUSH

Model Number	BW-400B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional 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 that the subject device's brush was stuck in the forceps channel and couldn't be remove during reprocessing.There were no reports of patient involvement.
Event or Problem Description
It was reported that the subject device's brush was stuck in the forceps channel and couldn't be remove during reprocessing.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the results of the device evaluation and the final investigation.The device was evaluated where no abnormalities were found that could have led to the reported event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it was not possible to identify the cause of the problem because the brush could not be removed from the scope and the brush could not be checked.The following is included in the device ifu: ·these instruments have been designed to be used for brushing the instrument channel, the balloon suction channel or the auxiliary water channel, and the guide wire port of the olympus endoscopes listed below.Do not use these instruments for any purpose other than their intended use.These instruments are shipped nonsterile and are intended for single use only.Do not attempt to reuse.·do not attempt to insert these instruments from the distal end of the insertion tube; it may get caught and become difficult to retrieve.Olympus will continue to monitor field performance for this device.

• Brand Name: MLA-BW-400B
• Common Device Name: 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): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21072170
• Report Number: 9614641-2025-00007
• Device Sequence Number: 18244994
• Product Code: MNL
• UDI-Device Identifier: 04953170297977
• UDI-Public: 04953170297977
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K874239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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-400B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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