MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AIR/WATER VALVE

Model Number	MH-438
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.The unknown fibrous material was found during the device evaluation.Following the confirmed reprocessing issue, olympus personnel sent the user facility a reprocessing questionnaire.Through the questionnaire, the user facility confirmed all reprocessing steps in accordance with the instructions for use (ifu).If additional information becomes available following the device evaluation, a supplemental report will be filed.
Event or Problem Description
The customer reported that following a completed reprocessing cycle with his olympus air/water valve, he pressed one of the buttons and a transparent fibrous material came out from the spring.There was no patient involvement during this event.
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.When the attached fibers were analyzed, olympus confirmed they were nylon fibers commonly found from a cleaning brush.Based on the results of the investigation, it is likely the foreign material would not have been removed even if the user conducted the reprocessing properly.A definitive root cause cannot be identified.The event can be detected/prevented by following the instructions for use, ¿chapter 6 reprocessing the accessories, 6.2 manually cleaning the accessories,¿ which states: "1.While immersing the air/water valve completely in the detergent solution, brush the holes of the valve (2 holes).2.Inspect whether there is debris on the bristles.3.Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.4.Repeat step 1 through 3 until no debris is observed upon inspection of the brush." olympus will continue to monitor field performance for this device.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER VALVE
• 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: 17744145
• Report Number: 9610595-2023-13335
• Device Sequence Number: 14818026
• Product Code: FDS
• UDI-Device Identifier: 04953170071249
• UDI-Public: 04953170071249
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: MH-438
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/03/2023
• 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
• Patient Sex: Unknown