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

Model Number	MAJ-1444
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the air/water valve was used in a case with heavy bleeding, thoroughly cleaned with the endoscope re-processor, and stored.The next day, before a procedure, blood was noticed dripping from the air/water nozzle of the gastrovideoscope.The issue occurred during preparation before use inspection for an unspecified procedure which was completed using another similar device.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot and serial number were not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.After checking the appearance of the device, it was confirmed the packing had cracked and that only washing of maj-1444 was not carried out.The inspection found the device packaging was damaged, causing pressure difference between the internal cavity and the external air, resulting in flow into the insufflation channel.It is possible that the damage occurred during cleaning.Based on the available information and results of the investigation, a definitive root cause could not be determined.The event can be prevented by following the instructions for use which state: chapter 3, preparation and inspection: warning: suction or insufflation boutons, which are suspected to be abnormal, are not only not functioning normally, but the device may be also 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: 19547899
• Report Number: 3002808148-2024-05478
• Device Sequence Number: 20515937
• Product Code: ODG
• UDI-Device Identifier: 04953170209680
• UDI-Public: 04953170209680
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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-1444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 06/27/2024
• 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: GF-UCT260 GASTROVIDEOSCOPE; OER-5 ENDOSCOPE REPROCESSOR
• Patient Sex: Unknown