MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U200H; BIOPSY NEEDLE

Model Number	NA-U200H-8019
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus single use aspiration needle was bent upon removing from package.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 21078888
• Report Number: 21078888
• Device Sequence Number: 17834068
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: (01)04953170380402(17)270630(10)47K
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/19/2024
• Report Date (Section F): 12/19/2024

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-U200H-8019
• Device Lot Number: 47K
• 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: 01/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 12/19/2024