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

Model Number	MAJ-824
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.Photographs of the service inspection were provided.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported that the reprocessor gave an error indicating an irregularity in circuitry (e83).During inspection of the reprocessor, examination showed the water filter (part number maj-824) had not been replaced since 2021.The device instructions for use for the reprocessor states monthly replacement of this filter is required.No adverse effects to patient reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, since the user did not read the instructions for use carefully, they incorrectly managed water filter replacement and used the filter even after its replacement period has expired.The event can be prevented by following the instructions for use (ifu) which state: "oer-aw operation manual.Chapter 7 routine maintenance.7.2 replacing the water filter (maj-824).Replace the water filter at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever an error code indicating water supply insufficiency [e01] is displayed.The water filter should be replaced by following the flow shown below.".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: 18419655
• Report Number: 9610595-2023-20583
• Device Sequence Number: 18133795
• Product Code: FEB
• UDI-Device Identifier: 04953170069482
• UDI-Public: 04953170069482
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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-824
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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-AW ENDOSCOPE REPROCESSOR
• Patient Sex: Unknown