MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE

Model Number	MAJ-1971
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number has not been provided at this time.An olympus field service engineer (fse) was dispatched to evaluate and repair the device.The fse replaced the yellow connector, and noted it was cracked due to wear.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.
Event or Problem Description
The customer reported to olympus technical assistance center (tac), during the reprocessing, the yellow connecting tube was noted to be broken.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the suggested event could not be concluded, although it can be presumed that the defect was caused due to external stress applied to lock lever of connecting tube, which broke the lever and the tube was unable to be connected.As a cause of external stress above, the user may have applied force toward incorrect direction.Three attempts were performed to obtain additional information, but no response was received from the customer.The event can be detected/prevented by conducting inspection below."8 preparation and inspection warning over time, the connecting tube will deteriorate because it is subject to wear with each use.If any of the following are found with the connecting tube, do not use it and replace it with a new one.Connecting a defective tube could prevent the effectiveness of the cleaning and high-level disinfection process.2 move the lock levers of the connecting tube 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: CONNECTING 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: 17442334
• Report Number: 9610595-2023-11007
• Device Sequence Number: 11386336
• Product Code: FEB
• UDI-Device Identifier: 04953170329623
• UDI-Public: 04953170329623
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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-1971
• Was Device Available for Evaluation?: Yes
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/05/2023
• 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 NO: OER-PRO SERIAL NO: (B)(6).
• Patient Sex: Unknown