MONOPOLAR SPATULA

Description of Event or Problem

WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED. IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGICAL PROCEDURE, AT THE BEGINNING OF THE SURGERY AND DURING THE LAPAROSCOPY PROCESS USING THE VALLEYLAB FT10 ENERGY PLATFORM AND A NON-(B)(6) MONOPOLAR SPATULA, THE ENERGY WAS INITIALLY SET AT 20 W FOR PURE CUT AND COAGULATION AND WAS THEN INCREASED TO 30 W DUE TO INSUFFICIENT TISSUE EFFECT, AFTER WHICH A MATCH-SIZED FLAME OCCURRED AT THE NON-(B)(6) MONOPOLAR INSTRUMENT UPON ACTIVATION VIA THE MONOPOLAR FOOT SWITCH. THE LIGASURE DEVICE WAS ALSO CAUGHT ON FIRE. THE MONOPOLAR INSTRUMENT WAS IMMEDIATELY WITHDRAWN FROM THE PATIENT¿S CAVITY AND DISCONTINUED, AND A LIGASURE MARYLAND DEVICE WAS INTRODUCED; UPON ACTIVATING LIGASURE ENERGY INSIDE THE PATIENT¿S CAVITY, AN ENERGY OVERLOAD WAS REPORTED AND THERMAL DAMAGE (BURNING) TO THE SURGICAL CANNULA OCCURRED. THE LIGASURE DEVICE WAS ACTIVATED MULTIPLE TIMES IN SUCCESSION JUST PRIOR TO THE BURN. AN EXPLORATORY LAPAROSCOPIC INSPECTION OF THE ABDOMINAL CAVITY IDENTIFIED THERMAL LESIONS (BURN) ON THE ABDOMINAL WALL WITH ASSOCIATED TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS, AND MELTED POLYMER DEBRIS INSIDE THE ABDOMINAL CAVITY THAT WAS REPORTED TO ORIGINATE FROM THE STRUCTURALLY COMPROMISED CANNULA. THE BURN WAS LOCATED AROUND THE TROCAR AND IN A REGION OF THE SMALL INTESTINE. PRESENCE OF MELTED POLYMER DEBRIS FELL INSIDE THE CAVITY, ORIGINATING FROM THE STRUCTURALLY COMPROMISED CANNULA, BUT IT WAS FULLY RETRIEVED. DUE TO THESE COMPLICATIONS AND TO ENSURE PATIENT SAFETY, THE SURGICAL TEAM CONVERTED THE PROCEDURE FROM LAPAROSCOPIC TO OPEN SURGERY TO RETRIEVE THE MELTED POLYMER DEBRIS FROM THE PATIENT AND TO CHECK AND TREAT THE BURN AND ASSESS THE ABDOMINAL WALL. THERE WAS NO ADDITIONAL MEDICAL PROCEDURE NEEDED TO REMOVE THE MELTED POLYMER DEBRIS FROM THE PATIENT. ANOTHER LIGASURE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THE EVENT WAS REPORTED TO HAVE LED TO EXTENDED HOSPITALIZATION, AND THE PATIENT WAS REPORTED AS ALIVE WITH TEMPORARY INJURY AND STILL RECOVERING IN THE HOSPITAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).