PK BUTTON FRONT LOADING ELECTRODE

Description of Event or Problem

DURING A SURGICAL PROCEDURE WHILE USING A PKS SP GENERATOR AND A WORKING ELEMENT (BOTH REPORTED SEPARATELY). THE SURGEON SAW A VISIBLE FLASH AND THE PATIENT JUMPED AS IF ELECTROCUTED. THERE WAS NO REPORT OF PATIENT INJURY. MELTING AND CHARRING WERE VISIBLE ON THE ELECTRODE, CABLE, AND WORKING ELEMENT.

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.