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

Model Number	NA-201SX-4022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the needle stylet broke off after the first needle pass.The issue occurred during a therapeutic endobronchial ultrasound bronchoscopy (ebus) procedure.The device was replaced with another needle and the intended procedure was able to be completed.Customer reported no impact on the procedure as the result of the event.There was no patient harm, no adverse event reported due to the event.No user injury reported.
Additional Manufacturer Narrative
The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Supplemental report(s) will be submitted should any relevant new information is available and or received.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 breakage of the stylet is thought to be caused by repeated bending loads applied to the stylet near the knob, which reduced the strength of the stylet and caused it to break.The buckling near the hard part is thought to be caused by the bending load applied to the needle tube when it is removed from the tray or when it is inspected before use, and the insertion part is bent.The deformation of the tip of the insertion tube and the foreign matter on the needle slider are thought to have occurred due to the use of the device in the procedure.However, a final root cause was unable to be identified.The following is included in the instructions for use: ¿should the stylet be bent, discontinue use of this product.The stylet may break or it may be difficult to insert or remove it.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on device return evaluation and response to follow up.Additionally, the lot number of the device was updated from lot 1zv to lot 1zv 29.Communication regarding the event reported conveyed the following : the needle did not break off inside the patient, no patient harm.The stylet fell off, prior to insertion into the scope.The subject device was received at olympus san jose service business center on october 17, 2022.Device evaluation, the following findings were noted : visual inspection performed on the as is received condition of the device; observed that the insertion portion located near the boot is kinked.The device was examined through the aspiration port and identified a portion of the style wire.The stylet knob was detached from the style wire and was not returned for evaluation.The distal end of the insertion portion is slightly deformed however there are no sharp protrusions or edges.Inspection performed by gently ran fingertips over the entire length of the sheath and felt a kink near the boot as well as several minor crushed areas.There was minor dried foreign material identified on the needle slider.Testing performed - pushed the lever to unlock the needle adjuster and pushed the needle slider in the distal direction until it stopped.The needle was extended and identified a portion of the style wire coming out of the distal end of the needle.The needle appears to have no signs of damage or missing portions.The needle length was measured at approximately 37.67mm.Device was fully retracted the needle back inside the sheath and pushed the lever to lock the needle adjuster.The sheath adjuster knob was turned counterclockwise and verified the sheath adjuster knob moved smoothly.The sheath adjuster knob was moved far as possible, and the sheath adjuster knob was tightened by turning it clockwise.The connecting-slider was moved back and forth smoothly with no issues.Investigation is ongoing.This report will be supplemented accordingly following investigation.

• 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: 15578528
• Report Number: 9614641-2022-00446
• Device Sequence Number: 6707029
• Product Code: FCG
• UDI-Device Identifier: 04953170389900
• UDI-Public: 04953170389900
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: NA-201SX-4022
• Device Lot Number: 1ZV 29
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/27/2022
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 11/22/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/07/2022; 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2021
• 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