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

Model Number	NA-U401SX-4022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.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
A clinical specialist reported to olympus, (3) single use aspiration needles were melted, and distal end of the sheath was broken.There was no report of patient harm associated with this event.Related patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the customer's complaint was not confirmed but rather "the sheath tip was damaged.In addition, the following malfunctions were found during a visual inspection on the ¿as received¿ and observed foreign material around the needle tip and on the stylet, indicating the device has been used.No damage was noted to the handle, slider and locking mechanism and the insertion tube.The distal end sheath has tears and appears to be a little melted.When manipulating the handle slider back and forth the needle was able to extended and retracted.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, the cause of the event is likely due to the internal parts of the endoscope (metal pipes) came into contact with the sheath, causing increased frictional resistance, which may have deformed the sheath due to increased frictional resistance.However, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: ·do not round the insertion part smaller than 15 cm in diameter.The aspiration biopsy needle may break.·when removing the product from the tray, remove the insertion part after removing and holding the handle.If you first remove the insertion tube and hold it, then remove the control section, the insertion tube may be deformed.·do not insert the aspiration biopsy needle while the endoscope is angled.Damage to the endoscope or aspiration biopsy needle may result.·return the up/down angle lever of the endoscope to its neutral position before inserting the aspiration biopsy needle into the endoscope.Insertion with the angle fixed may damage the endoscope or aspiration needle.·do not forcefully insert the aspiration biopsy needle into the endoscope.It may suddenly protrude from the tip of the endoscope, resulting in perforation, major bleeding, mucous membrane damage, or damage to the endoscope or aspiration biopsy needle.Also, if the resistance is high and insertion is difficult, return the angle of the endoscope until 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: 17891067
• Report Number: 9614641-2023-01482
• Device Sequence Number: 17999582
• Product Code: FCG
• UDI-Device Identifier: 04953170388323
• UDI-Public: 04953170388323
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K160098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: PW308590
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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