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

Model Number	MAJ-1816
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, during reprocessing, the extra low flow gas tube had black foreign substance.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The serial number of the subject device was not provided.The subject device has been returned to olympus for evaluation and the reported issue was confirmed.It was noted, a foreign object was confirmed inside the device, though it was not black.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer answered the following: did you disinfect the surface of this product with gauze moistened with disinfectant ethanol? (did you soak it in water or in disinfectant solution?) no.Did you use a hard cloth to clean the dirt? the surface is wiped with disinfectant alcohol, but gauze, etc.Is also used.Have you ever used it without drying it thoroughly after cleaning? there is a possibility.When autoclaving was previously recommended, autoclaving was performed, but due to the recommendation change, alcohol wiping is now used.After changing it, a foreign object occurred.As for the foreign matter, i think it may be mold caused by the inflow of steam.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 foreign material was unable to be identified and the root cause was unable to be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to h6 (3331 was inadvertently added on the previous report and should be removed).The foreign material appeared to be mold.The previous investigation results do not change.Olympus will continue to monitor field performance for this device.

• Brand Name: EXTRA LOW FLOW GAS TUBE
• Common Device Name: EXTRA LOW FLOW 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: 17344615
• Report Number: 3002808148-2023-07235
• Device Sequence Number: 12384143
• Product Code: FCX
• UDI-Device Identifier: 04953170262562
• UDI-Public: 04953170262562
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2023

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-1816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 09/15/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/07/2023; 09/21/2023
• 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: MODEL NUMBER: UCR, NO SERIAL NUMBER PROVIDED
• Patient Sex: Unknown