MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number NA-U401SX-4022

Device Problem Mechanical Problem (1384)

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

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

The customer discarded the device and therefore, will not be returned to olympus for evaluation.Since the subject device was not returned for investigation, the reported event could not be confirmed.Based on the investigation results from similar complaints in the past, it is possible to infer its cause from the description.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, it is likely the needle tube detached from the aspiration port due to an excessive angle of the endoscope causing the resistance to increase when sliding the needle tube resulting in the user feeling resistance during the procedure, or an attempt was made to forcefully retract the needle tube into the slider which applied a force greater than the usual resistance to the fixed portion of the needle tube in the aspiration port, causing the needle tube to be detached.The device's instruction manual provides the following warnings, which may help to prevent the issue: "do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument." "do not insert this instrument when the endoscope is angulated.This could damage the endoscope and/or this instrument." "do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument." olympus will continue to monitor field performance for this device.Customer discarded the device.

Event Description

The user facility reported contact between the handle (which is used to move the needle up and down) and the needle was lost after three to four samples were taken during a diagnostic endobronchial ultrasound guided fine needle aspiration procedure.The handle was not completely loose and could be moved a few centimeters up and down, but the needle remained in the lung tissue.The scope was removed from the patient with the needle still attached.The needle was then removed from the scope.Another needle was used to complete the procedure.The procedure took longer than anticipated but did not result in injury or harm to the patient.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13524920
• MDR Text Key: 296323161
• Report Number: 8010047-2022-02912
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388323
• UDI-Public: 04953170388323
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2022

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
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4022
• Device Lot Number: KR124723
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1