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

Model Number	MAJ-2318
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 there was an error message occurred (error e16) during reprocessing of the water filter.The issue occurred during preparation for use for an unspecified procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.New information added to the following fields: d8, d10, and h6.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, although the root cause was unable to be specified, it is likely the event occurred because the replacement period of the water filter was overdue (replaced once half a year).It is considered that the user did not thoroughly read the instruction manual and the mismanaged the method of the water filter replacement, leading to the subject event.Disinfection of the water supply piping had not been implemented due to the user not thoroughly reading the instruction manual and having a lack of knowledge of the device.The event can be detected and prevented by following the instructions for use which state: "instructions for oer-4 operation manual: chapter 7 ¿routine maintenance¿ section 7.2 ¿replacing the water filter (maj-2318)¿ replace the water filter periodically, at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever the error code [e01] indicating water supply insufficiency is displayed.Instructions for oer-4 installation manual: chapter 4 ¿installation of equipment¿ section 4.18 ¿checking the functions¿ warning: perform disinfecting the water supply piping in the following cases.- before using this equipment for the first time (after installation of the water filter).- immediately after replacement of the water filter.- whenever bacteria in the water supply piping is identified.- before using the equipment when it has not been used for a long time.Use the acecide disinfectant solution in the equipment for disinfection of the water supply piping." 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: 20224846
• Report Number: 9610595-2024-18394
• Device Sequence Number: 7419101
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OER-4(BNO.2825938)
• Patient Sex: Unknown