SONASTAR XS-CURVED EXTENDED HANDPIECE

Description of Event or Problem

USED DURING CRANIECTOMY FOR TUMOR, IRRIGATION WILL NOT SHUT OFF AFTER TWO MINUTES AS DESCRIBED TO CUSTOMER. IRRIGATION WAS RUNNING CONTINUOUSLY FOR APPROXIMATELY 1 HOUR BUT WAS NOT UTILIZED DURING PROCEDURE, AT THAT POINT (400 CC OF FLUID). SUCTION WAS ON ZERO, HOWEVER, IT WAS SUCTIONING. SURGEON STATES THAT IT WAS TOO MUCH. PLUGGED IN COAGULATION AND BOVIE, TURNED IT ON, UNIT CONTINUALLY RAN. UNABLE TO TURN IT OFF. THEY MUST UNPLUG FROM WALL. NO ALARMS ON DEVICE AND ULTRASONICS WERE NOTED AS RUNNING FINE. AT THE TIME OF THE CALL THE PATIENT HAD NOT SUFFERED ANY ADVERSE EFFECTS AS A RESULT OF THE INCIDENT. SURGERY WAS PROLONGED APPROXIMATELY 1 HOUR.