PK BUTTON FRONT LOADING ELECTRODE
Received Jan 11, 2012 · Event occurred Dec 12, 2011
Report 9617070-2011-00014 · MDR key 2432850
Device
Generic name
Pk Button Front Loading Electrode
Manufacturer
Gyrus Medical Ltd.Model number
786500Catalog number
786500
Lot number
U1103124
Product problems
- Device Emits Odor
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS DEVICE IS CURRENTLY STILL UNDER INVESTIGATION AND TESTING AT OUR FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem
DURING A SURGICAL PROCEDURE AS SOON AS THE SURGEON BEGAN TO VAPORIZE, THEY SMELLED SMOKE. THE SURGEON FOUND CHAR MARKS AT THE CONNECTION OF THE BUTTON AND THE ORANGE CORD. SWITCHED OUT THE DEVICE AND IT WORKED FINED. NO PT HARM.