MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)

Model Number	MAJ-1985
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (biomed) received guidance from olympus¿s technical assistance center regarding the malfunction.The biomed was given instructions to check the o-ring.In addition, was provided instructions for use and instructions on o-ring replacement.To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
A biomedical engineer reported to olympus, the cylinder hose with switch-over valve was leaking gas.There was no report of patient harm associated with 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.Based on the results of the investigation, the report of gas leakage could not be confirmed.Since the device was not returned for evaluation, the cause of this reported event could not be identified.Furthermore, the customer reported that the issue was resolved, as they were able to use the yoke without additional washers after additional testing.This supplemental report includes information added to b5 and d8.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The following additional information was received from the customer: "i believe the issue we¿re having is due to the staff wanting to add additional washers when replacing the tanks.In the past, they had a different yoke that slides from the top and secure it using a small gray washer/spacer that comes with the new tanks.After doing some testing, we were able to use the yoke without additional washers, but the staff is still convinced that it needs to have additional washer.I believe we¿re good for now, and i¿ll be sure to reach out if i have any questions.".

• Brand Name: CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)
• Common Device Name: CYLINDER HOSE
• 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: 15848550
• Report Number: 3002808148-2022-04555
• Device Sequence Number: 6525153
• Product Code: HIF
• UDI-Device Identifier: 04953170324208
• UDI-Public: 04953170324208
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K110294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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-1985
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 01/09/2023
• 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