FDA Adverse Event Malfunction Summary report: N

VIZISHOT 2 FLEX

MDR report key: 20598108 · Received November 4, 2024

Report

Report Number
20598108
Event Type
Malfunction
Date Received
November 4, 2024
Date of Event
August 15, 2024
Report Date
September 12, 2024
Manufacturer
GYRUS ACMI, LLC
Product Code
KTI
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

ON [REDACTED DATE] DURING AN EBUS (ENDOBRONCHIAL ULTRASOUND) WITH DR. THE 19 GAUGE SINGLE USE ASPIRATION NEEDLE THAT WAS USED MALFUNCTIONED. DURING AN EBUS, A DISPOSABLE DEVICE IS PLACED THROUGH THE CHANNEL OF THE EBUS SCOPE TO COLLECT TISSUE. THIS DEVICE HAS A NEEDLE THAT COMES OUT OF THE END OF IT TO COLLECT THE SAMPLE AND THEN RETRACTS BACK IN WHEN NOT IN USE. AFTER DOING THE FIRST PASS OF TISSUE COLLECTING, THE DEVICE WAS WALKED OVER TO THE PATHOLOGY STATION SET UP IN THE ROOM. TO PUT THE SPECIMEN ONTO THE SLIDE APPROPRIATELY, THE NEEDLE NEEDS TO BE EXPOSED AND THEN A WIRE IS PASSED THROUGH TO PUSH OUT THE SPECIMEN. I TRIED SEVERAL TIMES TO EXPOSE THE NEEDLE, BUT THE NEEDLE WAS NOT COMING OUT THE END OF THE SHEATH. I ALERTED DR. THAT THERE WAS NO NEEDLE PRESENT AND THAT I HAD TRIPLE CHECKED IT. HE SWITCHED TO THE BRONCHOSCOPE TO MAKE SURE THERE WASN'T ANYTHING INSIDE THE PATIENT. HE DIDN'T FIND ANY PIECES OF THE DEVICE INSIDE THE PATIENT. IN AN EFFORT TO LOCATE THE NEEDLE AND BE CERTAIN IT WASN'T LEFT BEHIND, I CUT OPEN THE SHEATH OF THE DEVICE TO SEE IF IT HAD RETRACTED BACK INSIDE - WHICH IT HAD IN FACT DONE. THE NEEDLE WAS LOCATED WELL BEYOND WHERE IT SHOULD HAVE BEEN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
791450 VIZISHOT 2 FLEX BRONCHOSCOPE ACCESSORY KTI GYRUS ACMI, LLC NA-U403SX-4019

Patients

Seq Age Sex Outcome Treatment
1 1 MO Male