MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. WATER FILTER

Model Number	MAJ-2318
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the water filter of the endoscope reprocessor was replaced once a year.During the time that the filter was expired, an endoscope was reprocessed and used on a patient.There were no reports of patient harm or injury.
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 to the following fields: d4 model number d4 primary udi number g4 pma/510(k) number.
Event or Problem Description
No additional information received from the customer.
Event or Problem Description
No additional information from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: h6, h11 based on the results of the investigation, and since the device was not returned for evaluation, there was difference of recognition on device handling between the user and recommendation by olympus.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: WATER FILTER
• Common Device Name: WATER FILTER
• 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: 23531486
• Report Number: 9610595-2025-31172
• Device Sequence Number: 9020872
• Product Code: FEB
• UDI-Device Identifier: 04953170401473
• UDI-Public: 04953170401473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190969
• 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,Followup
• Report Date (Section B): 12/11/2025

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-2318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 11/19/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 11/17/2025; 12/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GIF-XP290N, S/N: (B)(6).; OER-4, S/N: (B)(6).
• Patient Sex: Unknown