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

Model Number	NA-U401SX-4022
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus employee reported that, when setting up for a case, the customer picked up her demonstration device and used it during the unspecified diagnostic procedure.The customer asked the employee to come into the facility to support a procedure as it had been a while since they performed this procedure.When she arrived, she brought in her demonstration 22g needle that was opened and had been used in a demonstration previously and touched by multiple people.The surgical room was not prepared and she was asked to help set up the instruments.She set down her demonstration needle in an area outside the sterile area in the surgical room.The customer requested her help to track down instruments needed in the procedure.When she returned she was told that the doctor wanted a 19g needle but one could not be located.When the employee came back from looking for a 19g needle, the doctor was using a needle in the case.It was not until later that she realized her demonstration needle was not where she left it and had been used by the doctor in the procedure.She informed the doctor that the needle was opened and used in other demonstrations and that other doctors had touched the device.There was no impact on the patient due to the event.
Additional Manufacturer Narrative
The device manufacturer date was unable to be determined for this device since the lot number was not provided.The device has not been sent to olympus for evaluation.Since the lot number of the device was unknown, the device history records for approximately one year from the date of the incident were checked and no abnormalities were found.Based on the results of the legal manufacturer's investigation, it is likely the reported event was caused by the handling of the demonstration product, as it was used in the procedure.As stated in the instruction manual, this product is a disposable product and should not be reused.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following, which is related to the complaint: "do not reuse this product.Reuse may lead to infection, tissue inflammation, etc., and the function cannot be ensured." olympus will continue to monitor field performance for this device.

• 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
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16312845
• Report Number: 9614641-2023-00164
• Device Sequence Number: 20354014
• Product Code: FCG
• UDI-Device Identifier: 04953170388286
• UDI-Public: 04953170388286
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-U401SX-4022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown