MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number	NA-U401SX-4022
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of needle tip was harder to see was not confirmed.When the ultrasound image was checked using an olympus scope, the aspiration biopsy needle was able to be seen.Also, the ultrasound reflecting part at the tip of the needle tube had no scratches or deformations.There was a tendency to bend near the tip of the insertion tube.As a result, of inspecting the protrusion and retraction of the needle tube, there were no problems.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported malfunction.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because the needle tube was removed from the scope's ultrasound imaging range, so it could not be seen in the ultrasound image.The bending of the needle, it is probable that the bending of the needle occurred because it was inserted and removed when the insertion section of the endoscope was tightly bent.However, a definitive cause could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
An olympus employee reported on behalf of a customer that it was harder than usual to see the single use aspiration needle tip under the ultrasound image.The unspecified diagnostic procedure was completed using a replacement device.There was no report of patient harm associated with this event.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17840857
• Report Number: 9614641-2023-01422
• Device Sequence Number: 17243653
• Product Code: FCG
• UDI-Device Identifier: 04953170388323
• UDI-Public: 04953170388323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2023

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-U401SX-4022
• Device Lot Number: 37K12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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