MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE CHANNEL-OPENING CLEANING BRUSH

Model Number	MAJ-1339
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device tested positive for an unexpected contamination.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
Correction is being made to previously submitted g3 - date received by manufacturer, which was not late.The correct date was 18-mar-2025.
Event or Problem Description
No new information reported from the customer.
Event or Problem Description
The customer later clarified that the previously reported allegation was made in error.
Additional Manufacturer Narrative
This report was sent in error; the customer later clarified that the previously reported allegation was made in error.No new reportable findings have been identified and no emdr is required at this time.If additional information becomes available, then it will be re-assessed for reportability and to determine if an emdr sr is required.

• Brand Name: SINGLE USE CHANNEL-OPENING CLEANING BRUSH
• Common Device Name: 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: 20904390
• Report Number: 9614641-2024-20074
• Device Sequence Number: 9180979
• Product Code: MNL
• UDI-Device Identifier: 04953170297458
• UDI-Public: 04953170297458
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2025

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: MAJ-1339
• Device Lot Number: V2309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 02/10/2025; 03/19/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 03/19/2025; 03/19/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown