MAUDE Adverse Event Report: GYRUS ACMI VIZISHOT2 FLEX; SINGLE USE ASPIRATION NEEDLE

Catalog Number NA-U403SX-4019

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2019

Event Type  malfunction  

Event Description

While the provider was conducting a inter-nodal biopsy of the patient's lung while using the 19g vizishot 2 flex single use aspiration needle, the tip of the interior metal needle and the tip of the exterior plastic/rubber sheath broke off into the patient lung.The provider who was performing the procedure did not feel comfortable removing the broken pieces, so a thoracic surgeon was called in and assisted with the removal of the broken pieces.There were no repercussions from this device breaking, but it was a certainly a near miss.

• Brand Name: VIZISHOT2 FLEX
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): GYRUS ACMI; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9409802
• MDR Text Key: 169044191
• Report Number: 9409802
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NA-U403SX-4019
• Device Lot Number: FR867141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24820 DA