MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; LUMINAL DEVICE FLUSHING TUBING SET, REUSABLE

Model Number	MAJ-2111
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connecting tube broke and cannot be connected.The issue occurred during an unspecified procedure.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction to g3 of the initial medwatch.The aware date should be 06-sep-2024.H4: device manufacturer date: the device was manufactured in january 2011 based on the three-digit lot number.The specific date could not be determined with that information.Based on the results of the investigation, it is presumed that the connecting tube could not be connected due to detachment of lock lever by external stress.As a cause of the external stress, the user may have applied force toward incorrect direction.However, a definitive root cause could not be determined.The event can be detected by following the instructions for use (ifu): 9 preparation and inspection, 3 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.

• Brand Name: CONNECTING TUBE
• Common Device Name: LUMINAL DEVICE FLUSHING TUBING SET, REUSABLE
• 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: 20168014
• Report Number: 9610595-2024-17914
• Device Sequence Number: 12527238
• Product Code: FEB
• UDI-Device Identifier: 04953170404061
• UDI-Public: 04953170404061
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K190969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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-2111
• Device Lot Number: 11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2011
• 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