MAUDE Adverse Event Report: Gyrus ACMI, Inc. Single Use Aspiration Needle NA-U401SX; Biopsy Needle

Model Number	NA-U401SX-4021-A
Medical Device Problem Codes	Material Frayed (1262); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This additional supplemental report is being submitted to provide the results of the final investigation.Updated field(s): h2, h4, h6: b17 to b01, d15 to d02 the device was returned to olympus for inspection, and the reported failure was¿confirmed.A definitive root cause could not be identified.Based on the results of the investigation, there was shredding and torn pieces of sheath but found that the needle could be extended and retracted smoothly.The most probable cause of the complaint is cause traced to component failure, likely due to stress of repeated use, external factors, or handling.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: Single Use Aspiration Needle NA-U401SX
• Common Device Name: Biopsy 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 ; +1(508)207-7661
• MDR Report Key: 50410655
• Report Number: 3011050570-2026-00840
• Device Sequence Number: 18797047
• Product Code: FCG
• UDI-Device Identifier: 04953170409974
• UDI-Public: 04953170409974
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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-A
• Device Lot Number: PW311575
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2026
• 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