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

Model Number	MAJ-1444
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While in discussions with the customer, he noted that about 50 ccs of a red liquid and a brown linear object came out from the tip.The customer did confirm that the most recent patient had no signs of infection.According to the physician who uses this product most often, he felt that it had been difficult to send water through for a ¿long time¿.Reportedly, there were ¿times when the condition was good and times when it was bad.¿ further inquiry revealed that after the case, the air/water channel cleaning adapter had not been used, and the solution was immediately brought to the sink and delivered with the injection tube.The customer went on to note that since it was troublesome to remove the balloon, the balloon channel may not be aspirated during the process.No cleaning brush was used during this process.No water or air supply inspection was performed after the case, and it is unclear whether the button had been replaced during the inspection or not.The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer reported that while his medical staff was washing after an eus-fna test, a thin red object came out from the tip of his olympus air/water value.Reportedly, after that, a red-brown object appeared also.As this was discovered following the completion of the procedure, this event had no impact on the patient of this case.While performing diligence concerning this event, it became clear that the user facility had been insufficiently reprocessing some of their olympus devices.This report is 6 of 14 being submitted to capture the series of insufficiently reprocessed devices by the same user facility.For the related files, please see reports with patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.No abnormalities were found.The device history record was unable to be reviewed for this device since the lot 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 the specific cause of the phenomenon was not established at this time.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿warning: suction or insufflation boutons, which are suspected to be abnormal, are not only not functioning normally, the device may be damaged or the patient or surgeon may be injured.¿ olympus will continue to monitor field performance for this device.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER VALVE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17623324
• Report Number: 3002808148-2023-08947
• Device Sequence Number: 20653782
• Product Code: ODG
• UDI-Device Identifier: 04953170355929
• UDI-Public: 04953170355929
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: MAJ-1444
• Device Lot Number: ¿¿
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/06/2023
• 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
• Patient Sex: Unknown