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

Model Number NA-201SX-4022

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an endobronchial ultrasound bronchoscopy (ebus) procedure, the user determined that the needle was not visible beyond the sheath when it was advanced.The user looked everywhere , used ultrasound to check all the puncture sites including fluoro checks.The user ended up finding the tip of the needle on the back table where the user prepared the tissue samples.According to the reporter, the user suspected that the needle might have broken in the patient on a previous pass and got lodged in the sheath, slipped out during the sample preparation.There was no patient harm or impact due to the incident.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and past similar case.Please see updated sections: g4, g7, h2, h3,h6 and h10.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause was not identified.Probable cause likely that the needle tube likely broke off by the following factors: the needle tube buckled significantly due to force to bend , which was possibly generated by movements of the patient during the procedure.The buckled needle tube then received force to straighten the bent.The bending and straightening reduced the strength of the needle tube until and finally broke it off.Historical review of complaints were performed.Review indicated 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.As stated on the ifu and as a preventive measure: 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.Olympus will continue to monitor complaints for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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
• MDR Report Key: 10134691
• MDR Text Key: 194528659
• Report Number: 8010047-2020-03235
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170180972
• UDI-Public: 04953170180972
• Combination Product (y/n): N
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

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
• Device Operator: Health Professional
• Device Model Number: NA-201SX-4022
• Device Lot Number: 99V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1