MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. Single Use Aspiration Needle NA-U401SX; Biopsy Needle

Model Number	NA-U401SX-4021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sheath of needle broke.

• 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: 50818354
• Report Number: 50818354
• Device Sequence Number: 10157760
• Product Code: FCG
• UDI-Device Identifier: 04953170409974
• UDI-Public: (01)04953170409974(17)290724(10)FR517640
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2026
• Report Date (Section F): 09/09/2026

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
• Device Catalogue Number: R5000691
• Device Lot Number: FR517640
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 119 LB
• Date Report Sent to FDA: 09/09/2026