MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8022
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the aspiration needle guidewire was difficult to insert and got stuck.The issue occurred during the therapeutic procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned, and the reportable malfunction was not confirmed.Based on the results of the investigation, a definitive root cause for the event could not be determined.However, it is likely that the guidewire may not be able to be inserted into the needle tube.Content of the instruction manual was confirmed.The instruction manual contains the following descriptions, and it warns against this event."do not operate the guidewire with excessive force.In particular, do not pull the guidewire if you feel resistance.Do not roll the insertion tube into a diameter smaller than 20 cm.This may cause the insertion tube to break.Do not use this product if the insertion part is broken, bent, cracked or otherwise deformed.Using a product with a deformed insertion part may lead to unexpected perforation, heavy bleeding or mucosal damage.If there is strong resistance making it difficult to insert the suction biopsy needle into the endoscope, do not force it in.Return the angle of the endoscope to the point where it can be inserted comfortably.If there is strong resistance making insertion difficult even after returning the angle of the endoscope, discontinue use.Forcing the needle into the endoscope may result in perforation, heavy bleeding, mucosal damage, etc., or it may cause damage to the endoscope or suction biopsy needle." olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported that the issue occurred during endoscopic ultrasound-biliary drainage procedure.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19724703
• Report Number: 9614641-2024-01418
• Device Sequence Number: 8275289
• Product Code: FCG
• UDI-Device Identifier: 04953170380488
• UDI-Public: 04953170380488
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: NA-U200H-8022
• Device Lot Number: 3XK05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown