MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. GAS TUBE

Model Number	MAJ-1741
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1/establishment name: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during reprocessing, sterilization was performed by the gas tube, but it was not flushed with fluid.There were no reports of patient harm.
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/serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned to olympus for physical evaluation.Based on the results of the investigation, the event was surmised to be the cause of reprocessing failure as sterilization was performed but was not flushed with fluid, which was recommended in the instructions for use.However, the root cause of the event could not be identified.The event can be prevented by following the instructions for use which state: 6.4 cleaning of co2 regulation unit, cylinder hose, gas pipeline adapter, the gas tube (maj-1741), low flow gas tube (maj-1742), and low flow gas tube (maj-1816) gas tube (maj-1741) cannot be immersed in fluids such as water and disinfectant solution.Do not autoclave or gas sterilize the instruments as this will damage them.Olympus will continue to monitor field performance for this device.

• Brand Name: GAS TUBE
• Common Device Name: GAS TUBE
• 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: 20546147
• Report Number: 3002808148-2024-10520
• Device Sequence Number: 12627406
• Product Code: FCX
• UDI-Device Identifier: 04953170239120
• UDI-Public: 04953170239120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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-1741
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/22/2024
• 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
• Patient Sex: Unknown