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

Model Number NA-U401SX-4021

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  Injury  

Event Description

The customer reported to olympus that during a diagnostic procedure, specimen retrieval, the catheter sheath fell apart, shredded or pieces came off.Nothing was left inside of the patient.The procedure was prolonged for sixty-five minutes to open a new device and complete the procedure.There were no reports of further patient or user harm associated with this event.

Event Description

The incident occurred during a fine needle aspiration (fna) of the patient¿s subcarinal lymph node and left hilar mass.The total duration of the procedure was 65 minutes.It was reported that the procedure was prolonged due to the need to open another needle.However, the exact time it took to open the new device was unspecified.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Type of Device: 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: 17452226
• MDR Text Key: 320322664
• Report Number: 2429304-2023-00251
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388248
• UDI-Public: 04953170388248
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/13/2023,11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4021
• Device Lot Number: KR114648
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention