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

Model Number NA-U403SX-4019

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Establishment: (b)(6).The device was returned to olympus for evaluation where service found the device was in two separate pieces.The sheath of the device was completely ripped off.The sheath was ripped off toward the proximal end of the device where it connects to the handle.The hypotube was still lodged in the sheath that had ripped off.The needle tip did not appear to have been broken off.No pieces of the device appear to be missing.The stylet of the device was inserted into the device and is unable to move freely; it is completely stuck inside the device.As the sheath is not present, the needle is constantly exposed.The sheath has remnants of blood, indicating it was used.The customer reported that the needle tip broke off, this was not confirmed, however the sheathing of the device was indeed broken off the device.The handle of the device was then cracked open to see of any possible damage was present to keep the stylet from moving.There was a kink in the needle noticed.After a good amount of force was applied the stylet was able to be pulled out completely.The stylet was then put back in, the resistance was felt at exactly where the kink was found.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, it is likely that the malfunction was caused by forcing the device through resistance and/or angulation.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): page 13 of the device 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." also, on page 12 of the device ifu, it says: ¿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.".

Event Description

The customer reported to olympus that the guide catheter broke off at the handle during insertion.The reported problem was found during a lymph node physical exam for suspected lung carcinoma.The intended procedure was successfully completed with a new needle.There was no clinically relevant prolongation of the procedure due to the defect.There was no harm or user injury reported due to the event.

• 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: lydia sakakeeny ; 800 west park drive; westborough, MA 01581 ; 6177976458
• MDR Report Key: 17032710
• MDR Text Key: 316259655
• Report Number: 3011050570-2023-00048
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• 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: KR248709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1