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

Model Number NA-U403SX-4019

Device Problem Material Puncture/Hole (1504)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, that single use-aspiration needle had a perforation of the working channel which was observed during a diagnostic puncture of mediastinal lymph node enlargements procedure.The procedure was completed with a new needle on the same scope.There was a slight delay to the procedure that did not endanger the patient.There was no harm or user injury reported due to the event.

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.The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that when initially advancing the needle, there was some major resistance.The distal hypo tube had a minor bend approximately 0.21 inches from the distal end of the sheath.Also, when retracting the needle, the needle would not fully going back into the sheath.After further inspection, it was found that the sheath was detached.There was some dried blood consistent with being used in operation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

The initial medwatch incorrectly reported the site registration number.The site registration number is (b)(4).

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.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely that heavy stress near the distal end of the sheath, the resistance when advancing the needle, and the bend in the hypotube led to the malfunction.The root cause is traced to the user.The event can be detected/prevented by following the instructions for use which state on page 13: "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." also, on page 12 of the device ifu, it states: ¿do not angulate the bending section of the endoscope abruptly while the needle is inserted into the instrument channel of the endoscope.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.¿ 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.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16736664
• MDR Text Key: 313258646
• Report Number: 3005975494-2023-00072
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 00821925043060
• UDI-Public: 00821925043060
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K163469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• 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: FR899329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• 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