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

Model Number	MAJ-2318
Medical Device Problem Codes	Device Reprocessing Problem (1091); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Based on the results of the investigation, it is likely that the user did not thoroughly read the instruction manual which resulted in mismanagement of replacing the water filter; however, a definitive root cause could not be identified.The device history record was unable to be reviewed for this device since the (serial/lot) number was not available.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The subject event can be detected and prevented by implementing the below instruction for use (ifu).Instructions, operation manual for oer-4 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.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that during reprocessing the water filter, an error code e01 occurred one minute before the end of the cleaning process.The camera that was being cleaned and then rinsed with water.This incident led to the facility changing the water filters once a year.There was no patient harm.

• 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: 19838069
• Report Number: 9610595-2024-15003
• Device Sequence Number: 15372526
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 (ENDOSCOPE PROCESSOR)
• Patient Sex: Unknown