SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE

Additional Manufacturer Narrative

THE USED SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE WAS RETURNED TO CONMED FOR EVALUATION ON 11-FEB-2016. A VISUAL INSPECTION NOTED NO DAMAGE OR VISIBLE DEFECTS WITH THE DEVICE. THE HANDPIECE WAS FUNCTIONALLY TESTED USING THE SYSTEM 7500 ABC ESU. THE DEVICE WAS ATTACHED TO THE ELECTROSURGICAL GENERATOR, THE GENERATOR WAS TURNED ON. AN ERROR CODE [2 - STUCK HAND OR FOOT ACTIVATION REQUEST] WAS DISPLAYED. THE HANDPIECE WAS UNPLUGGED AND THEN AGAIN PLUGGED BACK IN TO THE ELECTROSURGICAL UNIT. THE ERROR CODE WAS GENERATED AGAIN; RENDERING THE HANDPIECE UNUSABLE. THE HANDPIECE WAS DISASSEMBLED. A SOLDER BRIDGE WAS FOUND ON THE POWER SWITCH PRINTED CIRCUIT BOARD BETWEEN THE RED AND GREEN WIRES. THE SOLDER BRIDGE HAS CREATED A CLOSED CIRCUIT RESULTING IN POWER ACTIVATION WITHOUT DEPRESSING THE HAND CONTROL BUTTON. AN INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. THIS DEVICE WAS MANUFACTURED ON 17-JUN-2015. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NON-CONFORMANCES OR ABNORMALITIES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OF THE LOT CONTAINING FIVE HUNDRED TWENTY (520) UNITS, THIS IS THE ONLY ADVERSE EVENT REPORT THAT HAS BEEN RECEIVED. A TWO (2) YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY SHOWED A TOTAL OF EIGHT (8) SIMILAR REPORTS. ONLY ONE (1) SIMILAR ISSUE HAS RESULTED IN A PATIENT BURN. (B)(4). BASED ON AVAILABLE INFORMATION, IT IS BELIEVED THAT THE END-USER DID NOT FOLLOW THE PROPER SET-UP SEQUENCE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE END-USER TURNED THE ABC GENERATOR ON AND THEN PLUGGED THE ABC HANDPIECE IN TO THE GENERATOR WHICH RESULTED IN THE AUTO-ACTIVATION OF THE HANDPIECE. IF THE SET UP SEQUENCE AS PROVIDED IN THE IFU HAD BEEN FOLLOWED, AN ERROR CODE WOULD HAVE BEEN GENERATED BY THE ELECTROSURGICAL UNIT AND THE DEVICE WOULD NOT HAVE BEEN ABLE TO BE ACTIVATED. THE SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE IS A SINGLE USE DEVICE, INTENDED TO BE USED IN OPEN ELECTROSURGICAL PROCEDURES TO PROVIDE A MEANS OF COAGULATION. THE IFU STATES UNDER THE SECTION, INSTRUCTIONS FOR USE: WITH GENERATOR POWER OFF, INSERT THE ROUND CONNECTOR END OF THE HAND-CONTROL PENCIL CORD INTO THE "ARGON BEAM COAGULATOR" RECEPTACLE OF THE ABC ELECTROSURGICAL GENERATOR AND TURN CLOCKWISE UNTIL TIGHT. PLUG THREE-PRONGED END CONNECTOR INTO THE "BEAM HANDCONTROL" RECEPTACLE OF THE CONMED ABC ELECTROSURGICAL GENERATOR. TURN ON POWER. TO ACTIVATE THE ARGON BEAM, DEPRESS BLUE BUTTON ON THE HANDCONTROL PENCIL. NOTE: ARGON GAS WILL CONTINUE TO FLOW APPROXIMATELY FOUR SECONDS AFTER BUTTON IS RELEASED. TO REDUCE THE RISK OF PATIENT INJURY, THE IFU PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: ALWAYS PLACE ASSOCIATED, ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION, SUCH AS A HOLSTER, WHEN NOT IN USE, TO AVOID BURNS. TO AVOID BURNS, NEVER ALLOW CABLE ASSOCIATED WITH THIS DEVICE TO BE IN CONTACT WITH SKIN OF PATIENT OR TOUCHING OPERATOR.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE ACTIVATED DURING PRE-OPERATIVE TESTING WITHOUT DEPRESSING THE PUSH BUTTON TO ACTIVATE THE PENCIL. THERE WAS NO HARM TO THE OPERATING ROOM STAFF AND THERE WAS NO PATIENT INVOLVEMENT. THIS HANDPIECE WAS REMOVED FROM THE FIELD AND ANOTHER SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE USED TO COMPLETE THE PROCEDURE.