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

Model Number	NA-201SX-4021
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the single-use aspiration needle can no longer be blocked/stabilized during sampling.The knob can no longer secure the needle in the endoscope.The issue occurred during a diagnostic procedure involving the puncture of lymph nodes.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The actual device used in the procedure was not returned to olympus for evaluation, however, an unused device from the same lot number was returned on 28aug2024.The unused product was inspected and the customer's reported issue was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.As the actual product was not returned the manufacturer date cannot be determined.Based on the results of the investigation, a definitive root cause could not be determined as the actual product was not returned and the device that was returned and tested from the same lot had no malfunctions.However, based on the available information, the most likely reason the needle adjuster could not be fixed is because the needle adjuster lever was slid into a convex position rather than into the groove near the scale on the handle.The instructions for use (ifu) provides the following warning: "·before pushing the needle slider, confirm that the needle adjuster is fixed firmly.Be sure to firmly fix the needle adjuster.Otherwise, it could cause excess extension of the needle from the distal end of the sheath and perforation, bleeding, mucous membrane damage may result.·if you feel excessive resistance while operating the needle adjuster lever, release the needle adjuster lever once and fix it again.Otherwise, it could damage the needle adjuster lever and patient injury, such as perforation, bleeding, or mucous membrane damage could result ·pull the needle slider on the hand side until you feel a click." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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: 20004893
• Report Number: 9614641-2024-01652
• Device Sequence Number: 14690854
• Product Code: FCG
• UDI-Device Identifier: 04953170381911
• UDI-Public: 04953170381911
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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-201SX-4021
• Device Lot Number: 3YV
• Was Device Available for Evaluation?: No
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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