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

Model Number	NA-U200H-8025
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Opened package.Inserted needle through endoscope into biopsy site.Removed the stylet.Used needle to take biopsy.Pushed biopsy out with stylet.Removed stylet again.Flushed with saline, then air.Tried to replace stylet, but would not insert fully into the needle after repeated attempts.

• 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: 19258676
• Report Number: 19258676
• Device Sequence Number: 11408592
• Product Code: FCG
• UDI-Device Identifier: 04953170402500
• UDI-Public: (01)04953170402500
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/17/2024
• Report Date (Section F): 04/17/2024

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-8025
• Device Lot Number: 2ZK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White
• Date Report Sent to FDA: 04/17/2024