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

Model Number NA-U403SX-4019

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.A visual inspection was performed and found dried blood inside needle sheath consistent with use.The hypo tube is in place at the distal end.The needle tip is slightly bent and had been pulled away from the hypo tube.Functional test was performed.The handle was pushed/pulled a few times but was not able to extend needle as the needle was blocked by the hypo tube.It was observed that the sheath could be pushed/pulled at the handle boot and bunched up.The customer reported issue of sheath separate at the hub was confirmed due to the damaged sheath.In addition, it was found that the stylet got stuck inside the device, and the gray stopper was missing (likely removed from the shaft by user).However, the handle lock, sheath adjuster, screw, connecting slider are all functioning smoothly and correctly.Investigation is ongoing.This report will be supplemented accordingly following investigation completion.

Event Description

It was reported that an issue of the sheath separates at the hub preventing the needle from extending out occurred on the device with model na-u403sx-4019.According to the reporter, the issue occurred on separate events.One event occurred on (b)(6) 2022 and the second event occurred on (b)(6) 2022.According to the reporter, the issue occurred with quantity of six (six) devices with different lot numbers.Two (2) out of the six lot numbers are the same lot number (kr189775).Three (3) devices failed on february 3 and three (3) devices failed on (b)(6) 2022.The report did not stated which date which lot number the issue occurred.The procedure performed for both events was an ebus (endobronchial ultrasound bronchoscopy).The intended procedure for the two event according to the reporter was able to be completed using similar device.The lot number used to complete the procedure not provided.There was no patient harm or injury reported on both of the event.No user injury reported.This report is related to reports with patient identifiers (b)(6).

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, a definitive root cause could not be established.It is considered most likely that the observed failure is a known phenomenon caused from forcing the device through resistance and/or the distal sheath end being maneuvered out of clear visual sight.The instructions for use (ifu) states the following: do not force the instrument if resistance to insertion is encountered.Confirm the endoscope is straight and in the neutral position.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." the ifu continues: do not extend the sheath from the distal end of the endoscope without confirming it in the endoscopic field of view.Otherwise, it could cause patient injury, such as perforation, pneumothorax, bleeding, or membrane damage.It could also damage the endoscope and/or instrument" olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: VIZISHOT 2 FLEX
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 4848965250
• MDR Report Key: 13696733
• MDR Text Key: 290186027
• Report Number: 3011050570-2022-00024
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 00821925043060
• UDI-Public: 00821925043060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U403SX-4019
• Device Lot Number: KR195574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1