MAUDE Adverse Event Report: GYRUS ACMI, INC. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number	NA-U401SX-4021
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being supplemented to provide a re-evaluation of the reported condition.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: component failure due to stress.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
The mdr supplemental report is being submitted to provide updated fields and final investigation results.Updated fields: d8, d9, h2, h3, h4, h6, h11.The device was returned for evaluation and the customer's allegation was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: cause not established.Olympus will continue to monitor the performance of this device.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the tip of the sheath on the aspiration needle is being shorn/split when passing the needle through.The reported issue occurred during a therapeutic linear endobronchial ultrasound (ebus), which was completed using another device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was not returned to olympus for inspection; therefore, the reported failure was not confirmed.Based on the results of the investigation, and since the device malfunction was not confirmed during evaluation, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable cause of the complaint is cause not established.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.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23496772
• Report Number: 3011050570-2025-01288
• Device Sequence Number: 8965696
• Product Code: FCG
• UDI-Device Identifier: 04953170409974
• UDI-Public: 04953170409974
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/31/2026

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-U401SX-4021
• Device Lot Number: KR284627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 02/05/2026; 03/06/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/09/2025; 02/19/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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