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

Model Number	MAJ-1985
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer called olympus technical assistance center (tac) personnel to report his event.During the call, tac provided the customer with the replacement part number for the o-ring, then transferred the customer to customer service to order his replacement.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 his olympus cylinder hose with switch-over valve had compromised high pressure hose connection.According to the initial reporter the o-ring on his unit was bad.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.
Additional Manufacturer Narrative
This report is being submitted to capture additional information received from the initial reporter.That information is located in b5.Should further information be provided, another supplemental report will be submitted.
Event or Problem Description
Additional information was received from the initial reporter confirming that the user replaced the o-rings on two maj devices.According to the initial reporter those o-rings did not seal properly, and the co2 tanks were drained overnight.The staff forgot to turn off the tank valve.Reportedly, replacing the o-rings a second time with a proper seal resolved the issue.The customer confirmed there was no patient harm or interruption to the case.The customer did note that a minor leak of co2 was still present when the co2 tank was turned on.Extra o-rings were ordered for him to replace as needed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation the specific cause of phenomenon could not be identified.The device was not returned to legal manufacturer for evaluation.Olympus will continue to monitor field performance for this device.

• 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: 17070374
• Report Number: 3002808148-2023-05649
• Device Sequence Number: 12456452
• Product Code: HIF
• UDI-Device Identifier: 04953170324208
• UDI-Public: 04953170324208
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2023

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 06/14/2023; 07/14/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/20/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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