MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. LEAK TEST AIR TUBE

Model Number	MAJ-2127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the connectors on the leak test air tube kept breaking.The issue occurred during reprocessing.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 investigation.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.However, it is likely that the user applied external stress in the incorrect direction to the lock lever of the connecting tube, which broke the lever and the tube was unable to be connected.The user can detect the event by conducting inspection as follows per the instructions for use (ifu): "9.Preparation and inspection: 1.Visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities.2.Move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The device history record was unable to be reviewed since the exact manufacture date is unknown.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Olympus will continue to monitor field performance for this device.

• Brand Name: LEAK TEST AIR TUBE
• Common Device Name: LEAK TEST AIR TUBE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18827080
• Report Number: 9610595-2024-04449
• Device Sequence Number: 7878875
• Product Code: FEB
• UDI-Device Identifier: 04953170404160
• UDI-Public: 04953170404160
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190969
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024

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-2127
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 07/16/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/09/2024; 07/18/2024
• 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