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

Model Number	NA-U200H-8019
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation (guidewire stuck) was confirmed.A review of the device history record confirmed the device had no abnormalities related to the reported phenomenon.It has been less than one year since the subject device was manufactured.Based on the results of the investigation, the root cause of the stuck guidewire could not be determined.Depending on manufacturing variations within the na-u200h-8019 design values, there is a possibility that a 0.035 guidewire may not be able to be inserted through the needle tube.It is possible that the buckling of the needle tube increased the sliding resistance between the guidewire and the needle tube, making it impossible to insert and remove the guidewire.A likely cause of the buckling of the insertion portion may have been caused by the following factors: bending load was applied to the needle tube when it was removed from the tray.Bending load was applied to the needle tube during pre-use inspection.Bending load was applied to the needle tube during insertion and removal of the endoscope.The issue is addressed in the instruction manual: (drawing no.Rk0384 revision no.2) ¿do not insert the guidewire into the instrument.Otherwise, a guidewire may contact the sharp end of the needle tube, causing the coating to peel off and fall off inside the patient body.¿ olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus that when using a single use aspiration needle na-u200h, the guidewire was stuck and needed to be cut; the fine-needle aspiration (fna) needle was then removed.The therapeutic procedure (endoscopic ultrasonography-guided biliary drainage: eus bd) was completed with a similar device.There was no patient harm associated with the event.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17259516
• Report Number: 9614641-2023-00933
• Device Sequence Number: 5899124
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: 04953170380402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151738
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2023

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-U200H-8019
• Device Lot Number: 35K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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