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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device will not be returned to olympus for evaluation, due to being discarded.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A customer reported to olympus, the sheath of an aspiration needle fell off when trying to get the sample out.The event occurred during an unspecified therapeutic procedure.There was no report of patient harm.

Manufacturer Narrative

Correction to d4; the lot number is unknown.This report is being supplemented to provide additional information based on the approved final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

The olympus sales representative provided additional information stating that during the therapeutic ebus (endobronchial ultrasound) bronchoscopy, two needles failed.The first needle failed to come out of the sheath when passed through the scope.An attempt was made to use a second needle, but upon removal from the packaging, the sheath fell off of the needle before entering the bronchoscope.A third needle was used and ultimately worked.The failure of the needles resulted in a 10 minute delay while the patient was under general anesthesia.No error messages were reported.No patient harm or injury was reported.The related patient identifiers are as follows: (b)(6): na-u403sx-4019, lot kr383609.Reporting needle did not lock and failed to come out of the sheath (b)(6): na-u403sx-4019, lot unknown.Reporting the needle with loose/detached sheath.

• 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: 18194570
• MDR Text Key: 328827205
• Report Number: 3011050570-2023-00194
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• 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: KR3157044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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