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

Model Number	NA-U401SX-4021
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	12/17/2025
Type of Reportable Event	Serious Injury
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 during a diagnostic ultrasound bronchoscopy (ebus) puncture procedure, the needle broke off and became stuck in the patient's lymph node.The issue occurred during the fourth puncture of the lymph node.The patient had to be extubated, and the needle tip was retrieved using forceps.The examination was then completed using a replacement needle of the same type.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide correction to the initial mdr.The correct registered site is brooklyn park, not aomori.The registration number is (b)(4).Corrected fields: d3, g1, d4, h4.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d4, h2, h3, h6, h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection, and the reported failure was confirmed.The device evaluation found the needle was broken at a position about 13mm from the tip of the needle tube.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: the needle is broken when a load was applied to a needle that has been significantly bent and deformed in the direction of returning (stretching) it to a straight line.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: 23982174
• Report Number: 9614641-2026-00020
• Device Sequence Number: 4553832
• Product Code: FCG
• UDI-Device Identifier: 04953170409974
• UDI-Public: 04953170409974
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-U401SX-4021
• Device Lot Number: KR499658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 02/05/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/16/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown