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

Model Number NA-U403SX-4019

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The needle was not returned for evaluation.The cause of the reported event cannot be determined at this time.If the device is returned at a later time or if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during an unspecified procedure, while performing the first puncture the user noted the needle¿s sheath was pleated.A portion of the needle¿s sheath detached, when the user attempted to withdraw the sample.There was no report of a device fragment falling into the patient.The needle was rinsed and a hole was noted in the sheath.The user reported that the needle was replaced; however, the scope seemed damaged.The procedure was completed with the second needle.There was no significant delay with the procedure and no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation and legal manufacturer investigation.A single device was returned to olympus brooklyn park packaged in the original tray with tyvek lid and shelf carton.The tray was unsealed.The lot number was confirmed to be kr938841.The device was returned with the needle fully retracted, the stylet inserted.No additional accessories were returned with the device.The distal end is in good condition free from damage.The sheath adjustor and depth setter function as intended.The stylet passes smoothly.The distal tip is sharp and free from deformation or damage.During testing it was noted that the outer sheath is no longer securely anchored inside the handle, allowing the needle to become exposed unintentionally.There was no indication of a missing segment or a hole in the outer sheath as described in the event description.A syringe, similar to the one packaged alongside the na-u043sx-4019 was filled with water.Attached the luer on the proximal end of the device, the syringe was used to push water through the device.No holes in the pebax heat shrink layer or the outer sheath were noted.The water passed through the distal tip of the needle as intended.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.Lm reported that the most probable cause for the reported event is as follows: device history record was reviewed and showed the product met all specifications upon release.The user most likely experience the defect due to the sheath becomes damaged/stretched and/or pulls out from depth setter during needle deployment.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the observed reported failure is a known phenomenon likely resulting from forcing the device through resistance.A definitive root cause cannot be identified.Page 13 of the device instructions for use (ifu) (pn0008807_ah) addresses this: "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." olympus will continue to monitor the field performance of 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: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 11045797
• MDR Text Key: 238816554
• Report Number: 3011050570-2020-00184
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 00821925043060
• UDI-Public: 00821925043060
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K163469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: KR938841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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