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

Model Number	NA-201SX-4021
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, at preparation before use for a therapeutic lymph node puncture procedure (patient was under anesthesia), the needle adjuster could not be locked or unlocked.No injury reported.The user completed the case with another device and with no delay of more than fifteen (15) minutes.There was no patient harm and no injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
(b)(6).The subject device was received and evaluated.Device evaluation and inspection, the following were noted : inspection of the returned needle found the adjuster is bent and deformed.There is no protective clip at the position of the needle adjuster , this adjuster is for function: (to prevent the needle core adjuster from bending) during transportation.The needle adjuster is bent and cannot be pressed, causing the needle core to lock and cannot be adjusted.Functional test performed by gently moving the bent needle adjuster by hand, and after trying to restore the bending position of the needle adjuster, then the needle can be freely slid and the needle adjuster can be locked and released by pressing.Evaluation of the device, service inspection noted that the needle adjuster is made of plastic, which is easy to bend and deform under external force.It is suspected that it is caused by pressure during transportation or use and storage, which is not a product quality issue.Before unsealing, there is a protective clip in the package to prevent the needle adjuster from being pressed and bent.It is stated to remove the protective clip before use and make a visual inspection to confirm that the needle adjuster is not damaged.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 reported event was likely caused by not pressing the needle adjuster lever straight, which applied force in the diagonal direction to the needle adjuster lever.This likely deformed the needle adjuster lever and made it unable to slide in the locking direction.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿before pushing the needle slider, confirm that the needle adjuster is fixed firmly.Be sure to firmly fix the needle adjuster.Otherwise, it could cause excess extension of the needle from the distal end of the sheath and perforation, bleeding, mucous membrane damage may result.¿ ¿if you feel excessive resistance while operating the needle adjuster lever, release the needle adjuster lever once and fix it again.Otherwise, it could damage the needle adjuster lever and patient injury, such as perforation, bleeding, or mucous membrane damage could result.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15214561
• Report Number: 9614641-2022-00134
• Device Sequence Number: 17534515
• Product Code: FCG
• UDI-Device Identifier: 04953170240935
• UDI-Public: 04953170240935
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: NA-201SX-4021
• Device Lot Number: 19K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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