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Patient 1
ONE (1) "USED" THERMOGARD? DISPERSIVE ELECTRODE WAS RETURNED TO THE CONMED FOR EVALUATION. VISUAL INSPECTION NOTED A 1.5CM X 3CM CHARRED AREA AT ONE OF THE CORNERS DISTAL TO THE CORD SET. THE CHARRED AREA VIEWED UNDER MAGNIFICATION OBSERVED CHARRING OF GEL AND EXPOSED FOIL. THE PHYSICAL DAMAGE NOTED ON THE RETURNED DISPERSIVE ELECTRODE CONFIRMED THE REPORTED PROBLEM FOR CHARRING OF THE ELECTRODE GEL. THE INVESTIGATION REVEALED THERE ARE FOUR (4) POSSIBLE CAUSES FOR THIS RESULT TO OCCUR AND THEY ARE AS FOLLOWS: THE GEL MAY HAVE BEEN LIFTED FROM THE FOIL AS A RESULT OF RAPIDLY REMOVING THE LINER CAUSING THE FOIL TO BE EXPOSED AND LOCALIZING THE CURRENT AT THAT SMALL AREA. THE ELECTRODE MAY HAVE BEEN SET WHILE OFF THE PATIENT; IN THIS SITUATION THE ESU WOULD FAIL TO ALARM. IT IS ALSO POSSIBLE THAT THE ELECTRODE PAD MAY HAVE PEELED AWAY FROM THE PATIENT CAUSING THE ESU TO ALARM. IF THE GENERATOR IS RESET WITHOUT READJUSTING THE ELECTRODE, FURTHER UNPEELING OF THE ELECTRODE MAY RESULT AND CAUSE A LOCALIZED CURRENT FLOW AND PATIENT BURN. LASTLY, BECAUSE THE PAD WAS APPLIED TO THE HIP (WHICH IS ALSO NOT RECOMMENDED) THE BONY AREA OF THE HIP MAY CAUSE THE CURRENT TO LOCALIZE TOWARDS AREAS OF MORE VASCULARIZED LOW IMPEDANCE THUS LOCALIZING THE CURRENT FLOW RESULTING IN HEAT AND PATIENT BURN. IN THIS INSTANCE, THE FOUR (4) STATED POSSIBLE CAUSES ARE ALL RELATED TO END-USER ERROR REGARDING USE OF THIS DEVICE. THE FAILURE MODE IS ADDRESSED IN THE CONMED RISK DOCUMENT FOR ELECTROSURGICAL DISPERSIVE ELECTRODES AND ALSO ADDRESSED IN THE IFU. THE DEVICE WAS MANUFACTURED ON 11-FEB-2015. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NOTED DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED INCIDENT. SPECIAL ATTENTION HAS BEEN MADE TO REVIEW THE IMPEDANCE TESTS, GEL CURE TESTS AND PAD GEL WEIGHT TESTS WITH NO NONCONFORMANCE OBSERVED. OF THE LOT CONTAINING (B)(4) UNITS, THERE HAS ONLY BEEN THIS (B)(4) REPORT OF PATIENT BURN. A TWO YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY SHOWED A TOTAL OF (B)(4)SIMILAR REPORTS FOR PATIENT BURNS, INCLUDING THIS INCIDENT. DURING THIS SAME TWO YEAR TIME FRAME, OVER (B)(4) UNITS WERE SOLD WORLDWIDE, MAKING THE OCCURRENCE RATE FOR THIS FAILURE MODE (B)(4) PERCENT. IT SHOULD BE NOTED, OF THE (B)(4) REPORTS OF PATIENT BURNS, THERE HAS BEEN ONLY (B)(4) REPORT IN WHICH A SECOND SURGERY WAS PERFORMED TO TREAT THE BURN, SURGICAL DEBRIDEMENT. TO DATE, THERE HAVE BEEN NO PATIENT LONG TERM ADVERSE EVENTS REPORTED REGARDING ANY OF THE (B)(4) REPORTED INCIDENTS. THE THERMOGARD? DISPERSIVE ELECTRODE IS A DISPOSABLE, DISPERSIVE ELECTRODE USED FOR THE DISPERSION AND RETURN TO THE ELECTROSURGICAL GENERATOR OF THERAPEUTIC (RF) ENERGY INTRODUCED TO THE PATIENT PRODUCED AT THE ACTIVE ELECTRODE DURING ELECTROSURGICAL PROCEDURES TO REDUCE THE RISK OF PATIENT INJURY, THE INSTRUCTIONS FOR USE, IFU, PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: POWER OUTPUT SHOULD BE LIMITED TO 300 WATTS FOR LESS THAN 60 SECOND ACTIVATION INTERVALS IN ORDER TO MINIMIZE THE POTENTIAL FOR PATIENT BURNS. ALWAYS USE THE LOWEST POWER SETTINGS TO ACHIEVE DESIRED SURGICAL EFFECT. THERMOGARD AND THERMOGARD PLUSABC DISPERSIVE ELECTRODES ARE FOR USE WITH VARIOUS PATIENT POPULATIONS PROVIDING THERE IS SUFFICIENT SURFACE AREA TO ENSURE FULL CONTACT OF THE ELECTRODE WITH THE PATIENT'S SKIN. FAILURE TO ACHIEVE A GOOD SKIN CONTACT BY THE ENTIRE ADHESIVE SURFACE MAY RESULT IN ELECTROSURGICAL BURNS OR POOR ELECTROSURGICAL PERFORMANCE. DO NOT COIL DISPERSIVE ELECTRODE CABLE OR ALLOW THE CABLE TO OVERLIE OTHER ELECTROSURGICAL MONITORING CABLES OR EQUIPMENT AS THE UNINTENDED TRANSFER OF POTENTIALLY HARMFUL RF ENERGY MAY RESULT. AVOID SKIN TO SKIN CONTACT WHEN POSITIONING THE PATIENT, USING DRY GAUZE WHERE NECESSARY. IF PATIENT IS REPOSITIONED, RE-INSPECT DISPERSIVE ELECTRODE AND ALL CONNECTIONS. DO NOT RE-USE OR RE-LOCATE THE DISPERSIVE ELECTRODE AFTER INITIAL APPLICATION.