MAUDE Adverse Event Report: AIZU 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 during routine microbiological testing, the duodenovideoscope's cleaning brush tested positive for gram positive cocci.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 evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Correction: d9 (not returned), h8.Additional information: h6, h11.The customer later clarified that the single use disposable brush, not intended to be reprocessed was positive and that the corresponding scope's culture was negative.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction to the device details: section d, h4, h6 (component).

• Brand Name: SINGLE USE CHANNEL-OPENING CLEANING BRUSH
• Common Device Name: CLEANING BRUSH
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20870294
• Report Number: 9610595-2024-23789
• Device Sequence Number: 20980573
• Product Code: MNL
• UDI-Device Identifier: 04953170297458
• UDI-Public: 04953170297458
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220587
• 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): 05/02/2025

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
• Date Returned to Manufacturer: 11/08/2024
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 02/25/2025; 04/07/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/11/2025; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS BRUSH MAJ-1399.
• Patient Sex: Unknown