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

Model Number MAJ-1816

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

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.

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.

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
• Type of Device: 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
• MDR Text Key: 319574484
• Report Number: 3002808148-2023-07235
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04953170262562
• UDI-Public: 04953170262562
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MODEL NUMBER: UCR, NO SERIAL NUMBER PROVIDED