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

Model Number	NA-201SX-4022
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the single-use aspiration needle punctured the mandible in the needle.This occurred during an endobronchial ultrasound procedure.The procedure was completed with a back-up device.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.
Event or Problem Description
No additional information received from the 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.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS VIETNAM CO. LTD.; 8 street, long thanh ind. zone; an phuoc commune; dong nai province 81000 0; VM 810000
• Manufacturer (Section G): OLYMPUS VIETNAM CO. LTD.; 8 street, long thanh ind. zone; an phuoc commune; dong nai province 81000 0; VM 810000
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24429571
• Report Number: 3008040402-2026-00070
• Device Sequence Number: 16028265
• Product Code: KTI
• UDI-Device Identifier: 04953170389887
• UDI-Public: 04953170389887
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K251664
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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-4022
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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
• Patient Sex: Unknown