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

Model Number	NA-U401SX-4022
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.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 needle was determined to have broken off and dropped out.The needle tube was found to have been bent excessively due to a bending force that was applied when piecing the hard body tissue during a procedure.The needle tube broke when a force was applied when trying to straighten it.The definitive root cause of the reported issue could not be determined.The event can be detected/prevented by following the instructions for use (ifu): content of the instruction manual (drawing number: gk9897, revision number :03) was confirmed.The instruction manual contains the following descriptions, and it warns against this event.Do not round the insertion part smaller than 15 cm in diameter.The aspiration biopsy needle may break.When inserting the instrument into the endoscope, the distal end of the needle tube may be bent.When piercing the target, confirm the distal end of the sheath and needle tube in the endoscopic field of view and/or ultrasound image while considering such bending.Otherwise, patient injury such as perforation, bleeding, or mucous membrane damage may occur.Do not try to straighten a bent or deformed needle with your hands because the needle may break.Use a spare needle instead.Do not insert the aspiration biopsy needle while the endoscope is angled.Damage to the endoscope or aspiration biopsy needle may result.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 large and insertion is difficult.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported the single use aspiration needle would not come out from the tip, the needle had broken off.The issue occurred during an unknown surgery procedure.The procedure was completed after replacing it with a similar device.There were no reports of patient harm.
Event or Problem Description
It was reported the single use aspiration needle would not come out from the tip.The issue occurred during an unknown surgery procedure.The procedure was completed after replacing it with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
E1: establishment name: (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 19513137
• Report Number: 9614641-2024-01238
• Device Sequence Number: 20705197
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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-U401SX-4022
• Device Lot Number: 42K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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