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

Model Number	NA-201SX-4021
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative, on behalf of a user facility, reported that during a diagnostic endobronchial ultrasound procedure using the evis eus ultrasound bronchofibervideoscope with a single use aspiration needle, there was resistance.It was initially stated there was a hole on the insertion channel.Additional information was obtained to clarify the event.Upon the first pass with the first needle, the physician met resistance, so the pass was stopped.The needle was taken out of the scope, and it was noticed that the end of the catheter was broken off and the metal tip was sticking out.The needle was placed aside.A second needle was used, and another pass was tried.Resistance was felt again, so the needle was pulled out.The scope was removed, and the physician tried to put the catheter down the scope outside of the patient and could not advance the needle to the end of the scope.A second scope was used with another (third) needle to finish the procedure, and it was not cancelled.Due to the product issues, the procedure was prolonged by about 30-40 minutes.It was reported that the scope was plugged into the tower, and there were no error messages associated with this event.The patient's condition was not affected by this, and no interventions were required.Patient identifier (b)(6) is for the evis eus ultrasound bronchofibervideoscope.Patient identifier (b)(6) is for the single use aspiration needle.Patient identifier (b)(6) is for the single use aspiration needle.

• 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: 16950896
• Report Number: 2429304-2023-00116
• Device Sequence Number: 20586188
• Product Code: FCG
• UDI-Device Identifier: 04953170240935
• UDI-Public: 04953170240935
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2023
• Report Date (Section F): 04/21/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2023
• 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: EVIS ULTRASOUND BRONCHOFIBERVIDEOSCOPE-(B)(6).; SINGLE USE ASPIRATION NEEDLE ¿ LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown