PROGRESSIVE PUSH BUTTON PENCIL WITH PTFE BLADE

Description of Event or Problem

A TONSILLECTOMY AND ADENOIDECTOMY WAS PERFORMED ON A MALE WITHOUT INCIDENT UNTIL IT WAS DISCOVERED AT THE END OF THE PROCEDURE THAT THE PT RECEIVED A BURN ON HIS RIGHT LIP. PICTURES WERE TAKEN OF THE BURN AND THE BOVIE WHICH WERE SECURED AND LABELED. ANTIBIOTIC OINTMENT WAS APPLIED AND THE PROCEDURE WAS TERMINATED. SEVERAL DAYS LATER, THE DOCTOR FILED A REPORT ADDENDUM STATING THAT THE BURN OCCURRED BECAUSE OF EXPOSED METAL TOUCHING THE LIP AND THE TIP WAS UNUSUALLY DIFFICULTY TO INSERT INTO THE PENCIL, YET HE DECIDED TO USE IT ANYWAY. THE IFU CLEARLY STATES, IN PART, THE FOLLOWING PRECAUTIONS: "PRECAUTIONS AND WARNINGS - SECURELY ATTACH ALL COMPONENTS PRIOR TO USE. PRIOR TO USE, CHECK THE ELECTRODE CONNECTION TO THE ACCESSORY YOU ARE USING TO ENSURE PROPER FIT AND COMPATIBILITY. IMPROPER ELECTRODE INSTALLATION MAY RESULT IN INJURY TO THE PT OR OPERATING ROOM PERSONNEL BY ARCING AT THE ELECTRODE/PENCIL CONNECTION. EXAMINE ALL DEVICES TO BE CONNECTED TO THE ELECTROSURGICAL GENERATOR. AFTER CONNECTION, ENSURE THAT HEY ARE FUNCTIONING PROPERLY. BEFORE INSERTING OR CHANGING AN ELECTRODE, BE SURE THAT THE ACTIVE ACCESSORY IS NOT CONNECTED TO AN ELECTROSURGICAL GENERATOR OR THAT THE GENERATOR IS OFF (STANDBY). GRASP THE ELECTRODE BY THE INSULATING SLEEVE, AND INSERT THE ROUND SHANK INTO THE ELECTROSURGICAL ACCESSORY UNTIL THE INSULATING SLEEVE IS FULLY INSERTED. THE SHANK AND INSULATING SLEEVE SHOULD FIT SECURELY INTO THE ACTIVE ACCESSORY. IF THE SHANK AND/OR INSULATING SLEEVE DO NOT FIT, OR THE INSULATION WILL NOT INSERT, USE OF THIS PENCIL IS NOT RECOMMENDED." FACILITY WAS NOT AWARE OF ANY POST OPERATIVE COMPLICATIONS UNTIL WE WERE CONTACTED BY THE FAMILY'S LAWYER ON 10/07/09. INSURANCE CARRIER WAS PUT ON NOTICE IN 2009 AND ADVISED AGAIN ON 10/07/09 UPON RECEIPT OF LAWYER'S LETTER. DOSE OR AMOUNT: NA. DATES OF USE: 2009 DURATION UNK. DIAGNOSIS OR REASON FOR USE: TONSIL & ADENOID HYPERTROPHY. EVENT ABATED AFTER USE STOPPED: YES.