MAUDE Adverse Event Report: GYRUS ACMI, INC. SINGLE USE ASPIRATION NEEDLE; VIZISHOT 2 FLEX

Model Number NA-U401SX-4022

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

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.A photo of the subject device was provided for olympus evaluation, and investigation.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an endobronchial ultrasound bronchoscopy (ebus) tbna procedure the ebus needle was found kinked.According to the reporter, the user was using 19g needle and started at 11l then went to 7 then to 4r.It was at 4r when the user struggled to see the needle appear on the ultrasound image even though the user was pushing the needle out.The user tried to pull the needle out the scope, but felt a lot of resistance.When it was finally pulled the needle out, it was found out that the tip was bent and kinked, which was preventing the user from seeing the needle come out on the screen.The needle was replaced with a similar device, and the procedure was completed.There was a 5 minute delay in the procedure.No patient harm, or injury was reported.No user injury reported.

Manufacturer Narrative

On april 6, 2021, we confirmed the correct model number was "na-u401sx-4022", not an na-u403sx-4019.Therefore, we correct the model number from na-u403sx-4019 to na-u401sx-4022.

Manufacturer Narrative

This supplemental report is being submitted to withdraw mfr report#: 3011050570-2020- 00159.Olympus medical systems corp.(omsc) decided that there was no mdr reportable malfunction or adverse event.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: VIZISHOT 2 FLEX
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10924842
• MDR Text Key: 218958474
• Report Number: 3011050570-2020-00159
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• PMA/PMN Number: K163469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4022
• Device Lot Number: FR886366
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1