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

Model Number	NA-201SX-4022
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	05/22/2025
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 that during a diagnostic endoscopic bronchial ultrasound (ebus), the tip pf the subject device broke off inside the patient.The clinician was aspirating fluid from the patient for cytology.The subject device was withdrawn after one successful pass.When the clinician attempted to insert the needle again, it wouldn't go all the way in.The procedure was completed with a similar device.During the final inspection of the procedure, the clinician visually examined the area inside the patient and saw a shiny object.The broken piece was extracted with forceps.There was no patient harm reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide an update to the following fields: d3, d4, d9, g1, g4 & h4 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.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: the endoscope is pushed forward while the needle is placed in patient tissue due to misoperation by a heath care professional.The needle tube is exposed to a load in the shearing direction, resulting in fracture.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information submitted by the customer.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: 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: 22191153
• Report Number: 9614641-2025-00957
• Device Sequence Number: 8837447
• Product Code: KTI
• UDI-Device Identifier: 04953170389887
• UDI-Public: 04953170389887
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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-201SX-4022
• Device Lot Number: 4YV
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown