MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8022
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus employee reported on behalf of a customer during clinical use the single use aspiration needle did not show up well on ultrasound.The problem was resolved when the subject device was replaced with a similar device, it is thought the aspiration needle was the issue.The unspecified diagnostic procedure was completed using the replacement device.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the aspiration needle did not show up well on ultrasound was not confirmed.There was an ultrasonic wave reflecting part on the tip of the needle tube.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of this event (the needle tip does not appear on the ultrasound image) was unable to be identified.The following is included in the instructions for use: ¿be sure to identify the location of the distal end of the sheath with endoscopic or ultrasonic images before extending the sheath from the distal end of the endoscope.Otherwise, the distal end of the sheath may be excessively extended from the distal end of the endoscope, causing patient injury, such as perforation, bleeding, or mucous membrane damage.1.Pull the stylet knob out approximately 30 mm.2.Check the distance from the distal end of the sheath to the target area in the ultrasound image.3.Loosen the needle stopper knob by turning it counterclockwise, holding the needle stopper to set the penetration depth of the needle tube.4.Secure the needle stopper knob by turning it clockwise and confirm that the needle stopper is secured.5.Push the needle slider to extend the needle tube from the distal end of the sheath and pierce the target area keeping the handle section as straight as possible relative to the instrument channel port of the endoscope while observing the ultrasound image.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17342876
• Report Number: 9614641-2023-00996
• Device Sequence Number: 6524479
• Product Code: FCG
• UDI-Device Identifier: 04953170380488
• UDI-Public: 04953170380488
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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-U200H-8022
• Device Lot Number: 2YK25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown