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

Model Number	NA-U401SX-4022
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that while using the single use aspiration needle during a diagnostic endobronchial ultrasound-guided transbronchial fine needle aspiration procedure, leakage occurred from the joint of the device (body fluid when aspirated).The procedure was completed by switching to a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information provided by the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The evaluation was completed.During device evaluation, the phenomenon was not reproduced.As there are no abnormalities as well as in appearance, we could not determine the cause of the phenomenon based on the investigation result.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, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.However, it is likely the event occurred due to one of the following: ·deliver liquid with the needle tube housed in the coil sheath and the tip of the coil sheath closed.·after feeding the liquid with the needle tube housed in the sheath, grasp the operation part and coil sheath to make the insertion part into a u-shape.The following information is stated in the instructions for use (ifu): ¿·do not roll the insertion part smaller than 15cm in diameter.The aspiration biopsy needle may be damaged.·when removing the product from the tray, remove the handle and hold it in place before removing the insertion section.If you remove and hold the insertion tube first and then remove the control section, the insertion tube may become deformed.·do not insert the aspiration needle while the endoscope is angled.Damage to the endoscope or aspiration biopsy needle may result.·before inserting the aspiration biopsy needle into the endoscope, return the endoscope's up/down angle lever to the neutral position.Insertion with a fixed angle may result in damage to the endoscope or aspiration biopsy needle.·do not forcefully insert the aspiration biopsy needle into the endoscope.It may protrude suddenly from the tip of the endoscope, leading to perforation, major bleeding, mucosal damage, or damage to the endoscope or aspiration biopsy needle.If insertion is difficult due to strong resistance, return the angle of the endoscope to a point where it can be inserted without difficulty.¿ olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17581127
• Report Number: 9614641-2023-01193
• Device Sequence Number: 18364431
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

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: 22SK
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 09/19/2023
• Initial Report FDA Received Date: 08/19/2023
• Supplement Report FDA Received Date: 08/21/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2022
• 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: BF-UC260F ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Patient Sex: Unknown