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

Model Number	MAJ-2318
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation of the reported issue.In speaking with olympus technical assistance center (tac), the customer reported that the water filter was ordered, and the order was received with the correct labeling on the outside but when box is opened it contains pall corp ra154500 and it did not fit.Troubleshooting efforts were made and the customer was informed that the wrong part (outside of box is marked maj-2318 but filter itself show pall part# ra154500.The customer was reassured that this is correct.The customer expressed concern that it looked physically different than what they were used to.The customer was informed that if they had previously used the maj-824 previously it would look different, but it was indeed a correct part.Later, the customer installed the filter and it appeared to be fine.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the water filter was ordered from customer and order was received with correct labeling on outside but when box is opened it contains pall corp ra154500 and it did not fit.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The manufacture date of the device cannot be identified at this time since the serial/lot was not provided.Based on the results of the investigation, a definitive root cause could not be further established, since it was determined that the device was able to be attached without further issue.The device's shape had been changed (when it was changed from item maj-824 to maj-2318), but is still compatible without issue.The customer had alleged a deficiency with the part prior to attempting to fit it within the device.Upon attempting to fit the part, it worked without incident.This is not deemed misuse by the user - an exchange of knowledge between the user and manufacturer regarding the state of the new part's design was enough to resolve this event.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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20406824
• Report Number: 9610595-2024-20465
• Device Sequence Number: 12391690
• Product Code: FEB
• UDI-Device Identifier: 04953170401473
• UDI-Public: 04953170401473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/13/2024
• 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