MEGADYNE E-Z CLEAN

Description of Event or Problem

PT WAS HAVING A LAPAROTOMY WITH PANCREATICODUODENECTOMY AND LYMPH NODE DISSECTION FOR SUSPECTED CANCER. DURING CAUTERIZATION WITH BOVIE, THE TIP CAUSED A PINHEAD SIZED BURN HOLE TO THE PT'S BOWEL. THE BURN HOLE WAS THEN SUTURED AND THE PREVIOUS SURGERY WAS CONTINUED. THE PT CAME THROUGH THE SURGERY IN SATISFACTORY CONDITION. THE PT IS STILL HOSPITALIZED AND THERE DOES NOT APPEAR TO BE ANY SEQUELAE FROM THE BURN. ELECTRO-SURGICAL UNIT, MODEL FORCE TRIAD, S/N (B)(4), MFR VALLEYLAB/COVIDIEN WAS BEING USED ON THE PT DURING THE SURGERY AND IT WAS PULLED AND ANOTHER ESU WAS USED. THE MFR CHECKED THE DEVICE AND REPORTED TO OUR BIOMED DEPT ON (B)(4) 2012, THAT THERE WAS NO PHYSICAL DAMAGE NOTED ON THE DEVICE OTHER THAN NORMAL WEAR AND TEAR. IT IS SPECULATED THAT THE MEGADYNE E-Z CLEAN USED THAT DAY HAD DEFECTIVE INSULATION AND THAT IT CAUSED THE BURN HOLE. THE DEVICE WAS SAVED AND THE MFR WAS NOTIFIED ON (B)(4) 2012. THEY TOOK THE DEVICE FOR EVAL ON 4/2/2012.