MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number	MAJ-891
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
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 the forceps/irrigation plug (isolated type), the following was found during an endoscopic support specialist (ess) visit, the ess observed there was brown discoloration build up on the scopes and attachments also observed, the user facility was not using freshly prepared water for each rinse.There were no reports of patient involvement.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
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, a definitive root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor complaints for this device.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Common Device Name: FORCEPS/ IRRIGATION PLUG
• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21617820
• Report Number: 9610595-2025-03936
• Device Sequence Number: 6668434
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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-891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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