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

Model Number	NA-201SX-4022
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: doing an ebus [endobronchial ultrasound] procedure with dr.[redacted] and ebus needle was hard to flush specimen out of and unable to thread stylet back into ebus needle.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 23072427
• Report Number: 23072427
• Device Sequence Number: 20075083
• Product Code: FCG
• UDI-Device Identifier: 04953170389887
• UDI-Public: (01)04953170389887
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2025
• Report Date (Section F): 09/15/2025

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
• Device Catalogue Number: N5432330
• Device Lot Number: V5428
• 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: 09/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2025
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Date Report Sent to FDA: 09/15/2025