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

Model Number	NA-U200H-8022
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the single use aspiration needle was inserted into the patient and when the fielder guide wire set was attempted to be inserted it got stuck.The issue occurred during a therapeutic interventional endoscopic ultrasound procedure.The procedure was completed using a similar device.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.E1/establishment name: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the device evaluation and the legal manufacturer's final investigation.Corrected field: g2: health professional, company representative and distributor are not applicable to this event.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.The device was returned to olympus for inspection.And the customer's reportable malfunction was not confirmed.However, it is likely possible, that the malfunction did occur.Based on the results of the investigation, a definitive root cause could not be determined.However, depending on manufacturing variations within the design values, there is a possibility that the e0018450ag-2, may not be able to be inserted into the needle tube.The event can be prevented, by handling the device in accordance with the following instructions for use: 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.
Event or Problem Description
The procedure was extended for about 5 minutes to replace the device with a new one.The malfunction occurred during the middle of the 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: 19634247
• Report Number: 9614641-2024-01351
• Device Sequence Number: 8535486
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: 41K 25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: E-02779753; EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE; FIELDER GUIDE WIRE SET
• Patient Sex: Unknown