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

Model Number	NA-201SX-4022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 establishment name: (b)(6).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 the aspiration needle was broken.The issue occurred during preparation for use.The patient had not received anesthesia.The unspecified procedure was finished using another device.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 and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (d8) and to provide an update to fields (d9, h3, and h4).The device was evaluated by olympus, and the reportable malfunction was not reproduced.Additionally, there were non-reportable (non-pae) defects noted.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, it is likely that the reason the needle is no longer able to protrude is due to buckling of the sheath.It is possible that the buckling of the sheath was caused by the bending load on the needle tube when it was removed from the tray or during endoscopic insertion.However, the cause of the outbreak could not be determined, and the root cause could not be identified.The event can be prevented by following the instructions for use which state: "when removing the aspiration biopsy needle from the tray, hold the sheath so that it does not jump out of the tray.Removing the sheath without holding it may damage the insertion part of the aspiration biopsy needle.In addition, the elasticity of the insertion tube may cause the entire insertion tube to bounce, and the tip of the needle tube, sheath, or stylet may cause injury to the operator or patient." "do not round the insertion tube smaller than 15 cm in diameter.The aspiration biopsy needle may break." "do not insert the aspiration needle while the endoscope is angled.Damage to the endoscope or aspiration biopsy needle may result." 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: 19303551
• Report Number: 9614641-2024-01080
• Device Sequence Number: 17824663
• Product Code: FCG
• UDI-Device Identifier: 04953170389900
• UDI-Public: 04953170389900
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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-4022
• Device Lot Number: 3ZK
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EBUS-TBNA
• Patient Sex: Unknown