MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. MEDICAL GAS PIPELINE ADAPTOR (DISS) FOR UHI-3

Model Number	MAJ-1084
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gas pipeline adaptor connector is not fitting securely with the national institute of standards and technology (nist) fittings.This was causing the carbon dioxide (co2) tanks to empty due to the poor connection.This issue was found during installation.The adapter was replaced during an unspecified procedure and the procedure was completed using a similar device.As reported, the trust has subsequently had co2 hoses with connectors made to allow them to connect to co2 piped into the endoscopy rooms.There were no reports of patient harm.
Additional Manufacturer Narrative
Device was not returned for evaluation and could not be evaluated.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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.This report is related to mfrs 13646(1/5), 13639(2/5), and 13643(3/5) 13648 (4/5).

• Brand Name: MEDICAL GAS PIPELINE ADAPTOR (DISS) FOR UHI-3
• Common Device Name: GAS PIPELINE ADAPTOR
• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19093255
• Report Number: 3002808148-2024-03423
• Device Sequence Number: 17917117
• Product Code: HIF
• UDI-Device Identifier: 04953170140365
• UDI-Public: 04953170140365
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K014166
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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-1084
• Device Lot Number: NOT AVAILABLE
• 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: 11/07/2023
• Initial Report FDA Received Date: 04/11/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown