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

Model Number	NA-U200H-8022
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the single use aspiration needle fell off outside of the patient's body.The issue occurred during preparation for use in a diagnostic eus-fna (endoscopic ultrasound-guided fine-needle aspiration) biopsy procedure.The procedure was completed with another similar device.The patient was not anesthetized.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 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 returned to olympus for inspection.During evaluation, it was confirmed that there was a breakage at the border between the metal of the forceps port connection and the plastic of the actuator.Buckling occurred near the base of the insertion; the stylet could be pulled out, but resistance was felt at the buckling of the insertion during withdrawal.Based on the results of the investigation, no needle breakage was identified, but the needle was crushed, likely due to a bending load on the needle tube.However, a definitive root cause could not be identified.The event can be prevented by following the instructions for use which state: content of the instruction manual (drawing number: rk0385, revision number :03) was confirmed.The instruction manual contains the following descriptions, and it warns against this event.Turn the elevator control lever of the endoscope in the opposite direction of ¿ u to lower the forceps elevator before inserting the instrument.Otherwise, the distal end of the sheath may be blocked by the forceps elevator, which could cause it to extend abruptly from the distal end of the endoscope.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.Use slow short strokes to insert the instrument into the endoscope channel, do not insert the instrument abruptly.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.Do not force the instrument if resistance is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.If excessive resistance is encountered after reducing the angulation of the endoscope entirely, do not use the instrument.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.Do not coil the insertion portion with a diameter of less than 20 cm.This could damage the insertion portion.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.Be sure to check that the forceps elevator is down before withdrawing the instrument from the endoscope.When the needle slider is withdrawn with the forceps elevator up, the needles distal end cannot be completely retracted into the sheath.When the incompletely retracted needles distal end is withdrawn from the endoscope, the needles distal end extending from the sheath may cause damage to the endoscopes instrument channel.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.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: 19597434
• Report Number: 9614641-2024-01315
• Device Sequence Number: 8409956
• Product Code: FCG
• UDI-Device Identifier: 04953170380488
• UDI-Public: 04953170380488
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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
• Patient Sex: Unknown