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

Model Number	NA-201SX-4021
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus received a medwatch mw5120181 reporting that the single use aspiration needle was used for approximately seven passes into the lymph nodes during a procedure without any indication of an issue.On the last pass, it was noted that the needle tip was unattached from its shaft and in the lung tissue.It was intact and recovered by the physician using bronchial forceps.All parts of the device were inspected and found intact without fragmentation post procedure.The physician also performed a complete airway inspection, ordered a post-procedure chest x-ray, and discussed it with the patient's family in the post procedure conference.Additional information received from the customer clarified that the procedure performed was a diagnostic bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration, which was extended by five minutes and was completed with another device.The diagnostic outcome and patient's condition were not impacted by the failure.There was no further harm or user injury reported due to the event.

• 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
• MDR Report Key: 17720724
• Report Number: 2429304-2023-00289
• Device Sequence Number: 7148569
• Product Code: FCG
• UDI-Device Identifier: 04953170240935
• UDI-Public: 04953170240935
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/11/2023
• Report Date (Section F): 08/23/2023

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-201SX-4021
• Device Lot Number: 34V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRONCHOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown