MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX; BIOPSY NEEDLE

Model Number	NA-U401SX-4022
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sheath would not sit properly on the needle for ebus it kept retracting during ebus.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 24531189
• Report Number: 24531189
• Device Sequence Number: 10343226
• Product Code: FCG
• UDI-Device Identifier: 04953170409981
• UDI-Public: (01)04953170409981
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026
• Report Date (Section F): 02/20/2026

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
• Device Model Number: NA-U401SX-4022
• Device Catalogue Number: R5000692
• Device Lot Number: NA-U4015X4022
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/20/2026