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

Model Number	NA-201SX-4022
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.
Event or Problem Description
It was reported that during an endobronchial ultrasound (ebus), while completing the first sampling puncture, the needle broke off and was stuck in the patient.As a result, the fragment was retrieved from the patient.The procedure was completed as intended.
Additional Manufacturer Narrative
This report is being supplemented to provide the findings of the investigation.New information is reported in h6, and h10.The device referenced in this report was not returned to olympus for physical evaluation, it was discarded by the customer.Olympus checked the device history records (dhr )for reported lot, and found that there were no abnormalities in the items related to the reported event.The instructions for use shipped with the device provides the customer with the following instructions related to the event: when inserting the instrument into the endoscope, the distal end of the needle tube may be bent.When piercing the target, confirm the distal end of the sheath and needle tube in the endoscopic field of view and/or ultrasound image while considering such bending.Otherwise, patient injury such as perforation, bleeding, or mucous membrane damage may occur.Do not try to straighten a bent or deformed needle with your hands because the needle may break.Use a spare needle instead.Do not push the needle slider suddenly.Doing so may cause sudden needle protrusion, resulting in perforation, bleeding, or mucous membrane damage.It can also damage the instrument.Conclusion/summary: since the actual product could not be confirmed and there were no abnormalities in the manufacturing records, the cause of the occurrence could not be identified.A past similar case indicates that a buckled needle tube breaks if straightening force is applied to the buckling.It is also known the needle weakens when repeatedly bent and straightened as the metal used for it has such a nature.The needle tube likely broke off by the mechanism below.The needle tube buckled significantly due to force to bend it, which was possibly generated by movements of the patient during the procedure.The buckled needle tube then received force to straighten it.The bending and straightening reduced the strength of the needle tube until and finally broke it off.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE 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: 10616681
• Report Number: 8010047-2020-07090
• Device Sequence Number: 2793022
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 9ZV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1