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

Model Number	NA-U200H-8025
Medical Device Problem Code	Difficult to Insert (1316)
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
It was reported the aspiration needle was unable to be inserted into the stylet.The issue occurred during a gastrointestinal procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Correction to d4 of the initial medwatch from "2zk" to "2zk 12".Correction to d9 of the initial medwatch from "no" to "yes".Additional information h4: the subject device was manufactured in december, 2022.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the customer's complaint was reproduced.When the stylet was inserted, it felt stuck at the buckling area and could not be inserted.The buckling was due to the following: when an attempt was made to extract the specimen, the needle tube near the distal end bent.The needle tube bent due to a bending force.An attempt was made to insert the stylet once more, but it got caught at the bent area of the needle tube.As a result, the stylet could not be inserted into the aspiration port.However, a conclusive root cause could not be determined.The event can be detected/prevented by following the instructions for use which state: if the insertion portion has any malformations like kinks, bends, or cracks, do not use the instrument.Otherwise, unexpected perforation, bleeding, or membrane damage may occur.The handle section and sheath should be kept straight, when withdrawn from the endoscope.Otherwise, the sheath and/or needle tube may be bent, negatively affecting specimen extraction.If the stylet shows any excessive bent and other irregularities, do not use it.The stylet may be damaged or you may come across a resistance to insertion and withdrawal.If this event were to recur, it would not cause or contribute to a death or a serious injury 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: 19393079
• Report Number: 9614641-2024-01155
• Device Sequence Number: 6786351
• Product Code: FCG
• UDI-Device Identifier: 04953170402500
• UDI-Public: 04953170402500
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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-8025
• Device Lot Number: 2ZK 12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White