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

Model Number	NA-U401SX-4025N
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported during a therapeutic bronchoscopy using a single use aspiration needle, the needle broke during the last past during the bronchoscopy ultrasound portion of the procedure.The needle fell into the patient's lung and was retrieved with forceps.There was no injury or delay.The physician determined the yield was good as multiple passes were completed before the incident occurred.Patient's current condition is reported to be the same as pre-procedure as there was no injury to the patient and no treatment was required.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The broken needle was returned to olympus in a jar and visual inspection of the device found the insertion sheath with a slight bend at the handle boot area.The stopper was missing, possibly removed by user.However, the handle section was functional.The needle slider could extend and retract the needle without issue.The stylet was also present and could be removed or reinserted into the device without restriction.The insertion portion was smooth, and the distal coil was intact.Furthermore, the needle tube and its needle fragment were inspected under a microscope.Olympus observed that the broken needle tube had jagged edges, bend, and measured about 24mm in length.The distal tip of the needle fragment was bent and also measured about 10mm long.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The exact cause of the problem could not be conclusively identified.Based on the results of the investigation, it is likely the needle tube was broken by the following mechanism: 1.The needle tube buckled significantly due to bending force.It might have occurred due to the movement of the patient during the procedure.2.A load was applied to the bent needle tube in a direction to back to straight by pulling the needle slider.This caused the needle tube to bend severely.In addition, regarding buckling near the hard part, it is likely to have been caused by the following factors: - when removing from the tray, a bending load was applied to the needle tube.- during the pre-use inspection, a bending load was applied to the needle tube.- when inserting into the endoscope, a bending load was applied to the needle tube.The instructions for use have the following statement which can prevent the event: "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.".

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11314592
• Report Number: 8010047-2021-02526
• Device Sequence Number: 13632079
• Product Code: KTI
• UDI-Device Identifier: 04953170402012
• UDI-Public: 04953170402012
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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-4025N
• Device Lot Number: 09K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1