MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE

Model Number	NA-201SX-4021
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the single use aspiration needle came through the side of the sheath instead of the end.This issue occurred during the start of a diagnostic endobronchial ultrasound (ebus) bronchoscopy procedure that was completed with a similar device with delay.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
Updated field(s): d4, d9, h3, h4, h6, h11 corrected (field(s): h5 this supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection, and the reported failure was confirmed.Based on the results of the investigation, the device has a bent/kink in the sheath.However, the most probable cause of the complaint is due to component failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction for the final investigation.Correction to h6 reported d02 should have been d15.The device was returned to olympus for inspection, and the reported failure was not confirmed.Based on the results of the investigation, a probable root cause could not be identified.The device returned and reported failure was not reproduced.
Event or Problem Description
No additional information received from customer.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22883795
• Report Number: 9614641-2025-01428
• Device Sequence Number: 9604853
• Product Code: FCG
• UDI-Device Identifier: 04953170389917
• UDI-Public: 04953170389917
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

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: NA-201SX-4021
• Device Lot Number: 49V17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 02/09/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/22/2025; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown