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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported to olympus during a diagnostic endoscopic bronchial ultrasound "eubu" with fine needle aspiration procedure the needle broke inside the patient.The customer reported they are missing 2 inches and could not find it.The device was inspected prior to use.Visual inspection, x-ray, and ct scan were performed.The customer later confirmed the procedure was completed and the patient's anesthesia was delayed by 60 minutes.The patient was not admitted to the hospital, although had an extended time in phase ii while waiting for the ct results.There was no evidence on visual inspection, x-ray, and ct scan that the needle remained in the patient.The needle was never confirmed to remain inside the patient.There has been no further events or harm to the patient.Patient is stable and at home.

• 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
• MDR Report Key: 18132653
• Report Number: 2429304-2023-00352
• Device Sequence Number: 18080688
• Product Code: FCG
• UDI-Device Identifier: 04953170388323
• UDI-Public: 04953170388323
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2023
• Report Date (Section F): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-U401SX-4022
• Device Lot Number: KR337678
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/19/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown