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

Model Number	NA-201SX-4021
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
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 bronchoscopy procedure the doctor was getting samples, and a second doctor was asked to assist with the case to see if they could get better samples.After the linear portion was finished.The first doctor went back in to get a brushing of the lung wall when they noticed metal in the patient's airway.Upon looking at the needle, it was noted the top sheath/coiled spring part was missing.The piece was extracted.The procedure lasted longer than expected due to the extraction of the needle piece by only about five minutes.The event was noticed at the end of the procedure.The patient was under moderate sedation during the event.The customer indicated there was no patient injury.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d9, 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 top sheath/ coiled spring part was missing because it was broken.A root cause could not be identified.The most probable cause of the complaint traced to component failure caused by either excessive or inadequate physical force exerted on it by another object resulting in problems e.G.Wear, bending, deformation, fracture, fatigue.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
• 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: 23284666
• Report Number: 3008040402-2025-00013
• Device Sequence Number: 8844068
• Product Code: KTI
• UDI-Device Identifier: 04953170389917
• UDI-Public: 04953170389917
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/06/2026

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-4021
• Device Lot Number: 4XV
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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