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

Model Number	NA-U401SX-4021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that during an unknown procedure, this single use aspiration needle broke off inside the patient.The procedure was delayed with patient under anesthesia, however, the amount of time is unknown.The procedure was completed.There were no reports of patient or user harm associated with this event.
Event or Problem Description
This report is submitted to update field d4.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: 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: 16610689
• Report Number: 2429304-2023-00049
• Device Sequence Number: 20401268
• Product Code: KTI
• UDI-Device Identifier: 04953170402005
• UDI-Public: 04953170402005
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023
• Report Date (Section F): 02/23/2023

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-U401SX-4021
• Device Lot Number: KR257315
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/20/2023
• 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: Other
• Patient Sex: Unknown