ABC TRIPLE OPTION DISPOSABLE HANDPIECE

Additional Manufacturer Narrative

THE DEVICE IN QUESTION IS BEING HELD BY THE END-USER FACILITY RISK MANAGEMENT DEPARTMENT. CONMED IS IN COMMUNICATION REGARDING THE RETURN OF THE SUSPECT DEVICE IN ORDER FOR A QUALITY ENGINEERING EVALUATION OF THE DEVICE TO COMMENCE. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION A SUPPLEMENTAL REPORT WILL BE FILED. THIS MEDWATCH IS ASSOCIATED WITH MEDWATCH NUMBER 1720159-2013-00051; REPORTING ON THE CONMED (B)(4), ELECTROSURGICAL UNIT (GENERATOR), ASSOCIATED WITH THE REPORTED INCIDENT. (B)(4)DEVICE BEING HELD BY RISK MANAGEMENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ORTHOTOPIC LIVER TRANSPLANT, "ARGON BEAM COAGULATOR-HANDPIECE WITH BUTTONS IN USE (NO FOOT PEDAL) WAS RESTING IN POCKET OF BLUE OR DRAPE (PER USUAL USE). THE ARGON BEAM FIRED SPONTANEOUSLY, BURNING THROUGH THE DRAPE AND THE SURGEON'S GOWN AND SCRUB PANTS. SURGEON AND STAFF REPORT THAT NO ONE WAS TOUCHING THE ARGON BUTTONS. OTHER THERAPIES IN USE ON PATIENT: CARDIAC DRUGS. OTHER DEVICES IN USE ON PATIENT: LIGASURE, ARGON BEAM, AND SUTURE LIGATURES AND SYSTEM 7500 ABC S/N (B)(4)." COMMUNICATIONS WITH THE END-USER FACILITY RISK MANAGEMENT DEPARTMENT WE HAVE LEARNED THAT, "THE PATIENT WAS NOT INJURED BUT SURGEON RECEIVED A SMALL BURN ON HIS LEG BUT DOES NOT BELIEVE THAT HE RECEIVED ANY TREATMENT FOR IT."

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS A TRIPLE OPTION HAND CONTROL DISPOSABLE ARGON BEAM COAGULATOR HANDPIECE WITH BLADE ELECTRODE, TEN FOOT CORD AND HOLSTER. THE TRIPLE OPTION HAND CONTROL DISPOSABLE ARGON BEAM COAGULATOR HANDPIECE IS INTENDED FOR USE AS AN ELECTROSURGICAL HANDSWITCHING PENCIL WITH CUT AND COAGULATION CAPABILITIES. IN ADDITION, THE TRIPLE OPTION ABC HANDCONTROL PENCIL ALSO HAS THE MEANS OF CONDUCTING ARGON GAS AND ELECTROSURGICAL CURRENT TO THE SURGICAL SITE FOR THE PURPOSE OF COAGULATION. NO PRODUCT WAS RETURNED FOR EXAMINATION OR CONFIRMATION OF DEFECT OR CONFIRMATION OF A CONMED PRODUCT, FOR, THE END-USER FACILITY BIO-MED DEPARTMENT DISCARDED THE DISPOSABLE HANDPIECE AFTER THEIR IN-HOUSE TESTING OF THE HANDPIECE AND THE ESU. A DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW WAS NOT ACCOMPLISHED FOR THE DEVICE LOT NUMBER WAS NOT MADE AVAILABLE. A 24 MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR ARGON BEAM COAGULATOR HANDPIECES, LAPAROSCOPIC, SHOW THIS COMPLAINT IS AN ISOLATED INCIDENT FOR THE FAILURE MODE OF SELF-ACTIVATION REGARDING ALL DEVICES WITHIN THIS PRODUCT LINE. THE RISK ASSOCIATED WITH THIS FAILURE IS MITIGATED IN THE IFU, INSTRUCTIONS FOR USE, WHICH STATES IN THE SECTION TITLED CONTRAINDICATIONS: "THESE DEVICES SHOULD NEVER BE USED WHEN: IN THE PRESENCE OF FLAMMABLE GASES, FLAMMABLE PREP SOLUTIONS OR DRAPES, ...". THE IFU ALSO STATES IN THE WARNING SECTION: "ALWAYS PLACE ASSOCIATED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION, SUCH AS A HOLSTER, WHEN NOT IN USE, TO AVOID BURNS." THE IFU FOR THE DEVICE ALSO STATES TO, "REFER TO CONMED ABC ELECTROSURGICAL GENERATOR OPERATOR MANUAL PRIOR TO USE." THE CONMED ABC ELECTROSURGICAL GENERATOR OPERATOR MANUAL STATES UNDER GENERAL PRECAUTIONS THAT, "SAFE AND EFFECTIVE ELECTROSURGERY IS DEPENDENT NOT ONLY ON EQUIPMENT DESIGN, BUT ALSO ON FACTORS UNDER THE CONTROL OF THE OPERATOR. IT IS IMPORTANT FOR THE INSTRUCTIONS SUPPLIED WITH THIS EQUIPMENT BE READ, UNDERSTOOD, AND FOLLOWED IN ORDER TO ENSURE THE SAFE AND EFFECTIVE USE OF THIS EQUIPMENT." THE OPERATOR MANUAL ALSO STATES THAT, "THE RISK OF IGNITING FLAMMABLE GASES OR OTHER MATERIALS IS INHERENT IN ELECTROSURGERY AND CANNOT BE ELIMINATED BY DEVICE DESIGN." THE CONMED ABC ELECTROSURGICAL GENERATOR OPERATOR MANUAL ALSO STATES IN THREE DIFFERENT LOCATIONS THE FOLLOWING WARNING PRINTED IN BOLD PRINT: "WARNING: WHEN NOT IN USE, ACTIVE ACCESSORIES SHOULD BE PLACED IN A STERILE ACCESSORY HOLSTER. FAILURE TO DO SO MAY RESULT IN UNINTENTIONAL BURNS TO THE PATIENT OR PERSONNEL." COMMUNICATION WITH (B)(6), CLINICAL TECHNOLOGY AND BIOMEDICAL ENGINEERING AT THE END-USER FACILITY HAS COMMUNICATED WITH ME THAT HE TESTED BOTH THE ESU AND THE HANDPIECE IN QUESTION AND THE ESU WAS IN GOOD WORKING CONDITION, AND, HIS DEPARTMENT TESTED THE HANDPIECE IN QUESTION MULTIPLE TIMES WITHOUT ANY FAILURE EACH TIME. THERE COULD BE MULTIPLE OF POSSIBLE CAUSES FOR THIS FAILURE MODE. IMPROPERLY ASSEMBLED DEVICE COULD BE A POSSIBLE CAUSE OF THE FAILURE MODE. IN PROCESS INSPECTION AND VISUAL CHECKS WERE DONE TO ENSURE PROPER PRODUCTION OF THE DEVICES. THUS, ANY DEVICE DISCREPANCIES SHOULD BE DETECTABLE PRIOR TO PACKAGING. THE INVESTIGATION HAS DETERMINED THAT THE CAUSE OF THESE COMPLAINTS IS MOST LIKELY USE RELATED. PER THE SYSTEM 7550 OPERATOR MANUAL THE TIP OF THE NOZZLE (ABC HANDPIECE) MUST BE WITHIN 1CM OR LESS OF THE TISSUE SURFACE TO INITIATE THE BEAM. THE OPERATOR MANUAL GOES FURTHER AND STATES, "THE RECOMMENDED TECHNIQUE IS TO ACTIVATE THE ABC MODE WHEN THE DISTAL TIP IS APPROXIMATELY 5-7MM AWAY FROM THE TISSUE AND MOVE THE ACCESSORY TOWARD THE TARGETED AREA." THE ABC HANDPIECE WAS REPORTED IN THE MEDWATCH AS, "RESTING IN POCKET OF BLUE OR DRAPE (PER USUAL USE)". THE BOTTOM OF THE DRAPE POCKET WOULD HAVE BEEN WITHIN 1CM OF THE DISTAL TIP OF THE HANDPIECE WHERE THE DRAPE WAS ACTING AS "TISSUE SURFACE", AND, IF THE HANDPIECE ACTIVATED THE ARGON BEAM COULD HAVE BEEN INITIATED. THE MEDWATCH REPORT ALSO STATED THAT THE, "ARGON BEAM FIRED SPONTANEOUSLY BURNING THROUGH THE DRAPE AND THE SURGEON'S GOWN AND SCRUB PANTS". FOR THE SURGEON'S GOWN AND SCRUB PANT TO BE BURNED BY THE ARGON BEAM, THE SURGEON'S LEG WOULD HAVE NEEDED TO BE WITHIN 1CM OF THE DISTAL TIP OF THE ABC HANDPIECE, AND, IF THE SURGEON'S LEG WAS IN THIS LOCATION NEXT TO THE OR DRAPE POCKET, THER LEG WAS IN A NEAR ENOUGH PROXIMITY TO THE HANDPIECE BUTTONS TO ACTIVATE THEM BY LEANING ON THE DRAPE. FURTHERMORE, THE HANDPIECE IFU AND SYSTEM 7550 OPERATOR MANUAL BOTH STATE THE "WARNING: WHEN NOT IN USE, ACTIVE ACCESSORIES SHOULD BE PLACED IN A STERILE ACCESSORY HOLSTER. FAILURE TO DO SO MAY RESULT IN UNINTENTIONAL BURNS TO THE PATIENT OR PERSONNEL." THE HANDPIECE BURNING THROUGH THE OR DRAPE SHOW THAT THE END-USER FACILITY DID NOT PLACE THE SUPPLIED INSULATED HOLSTER FOR THE DEVICE INTO THE OR DRAPE POCKET PRIOR TO RESTING THE DEVICE IN THE POCKET. NO LABORATORY EXAMINATION WAS PERFORMED ON THE COMPLAINT PRODUCTS, AS NO DEVICE WAS MADE AVAILABLE. THERE MAY BE A MULTIPLE OF POSSIBLE CAUSES EITHER MANUFACTURING OR USER RELATED. THE COMPLAINT CAN BE NEITHER CONFIRMED NOR UNCONFIRMED AT THIS TIME; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. DISPOSABLE DEVICE DISCARDED BY END-USER.