LIGHTWAVE SUCTION ABLATOR

Description of Event or Problem

THE CUSTOMER REPORTED THAT THIS ABLATOR STARTED TO OPERATE ON ITS OWN WITHOUT DEPRESSING THE BUTTONS. THERE WAS NO INJURY AND MINIMAL SURGICAL DELAY AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED AS INTENDED.

Additional Manufacturer Narrative

INVESTIGATION FINDING: CONMED LINVATEC RECEIVED THIS DEVICE FOR EVAL. AN INVESTIGATION FOUND THE ABLATE BUTTON FUNCTIONAL AND THE COAG BUTTON INTERMITTENT. UPON DISASSEMBLY, THE PC BOARD WAS FOUND DISCOLORED WITH EVIDENCE OF CORROSIVE LIKE DEPOSITS ON THE COAGULATION CONTACT AND DOME SWITCH. IN ADDITION, MINIMAL ADHESIVE WAS FOUND ON THE HANDLE HOUSING AT THE BOND SEAM. THIS FAILURE MODE REMAINS UNDER INVESTIGATION.