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

Model Number	NA-U200H-8022
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the single use aspiration needle exhibited guidewire stuck the issue occurred therapeutic endoscopic ultrasound- guided biliary drainage.The procedure was completed using a similar device.There were no reports delay or 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 not returned to olympus for inspection, and the customer's reportable malfunction was not confirmed.Based on the results of the investigation, no root cause could be determined.The event can be prevented by following the instructions for use which state: 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.Olympus will continue to monitor field performance for this device.

• 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: 19473518
• Report Number: 9614641-2024-01208
• Device Sequence Number: 17148738
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: NA-U200H-8022
• Device Lot Number: 32K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA-U200H-8019.SINGLE USE ASPIRATION NEEDLE
• Patient Sex: Unknown