Additional Manufacturer Narrative · 1
INVESTIGATION OF THE REFERENCED COMPLAINTS HAS BEEN COMPLETED. THE ORIGINAL COMPLAINT STATING THAT "PT RECEIVED 3RD DEGREE BURN ON BUTTOCKS." WAS RECEIVED 11/11/97. THE TWO INCIDENT ESU UNITS AND THE DISPERSIVE ELECTRODE WERE NOT RETURNED TO ASPEN LABS OR CONMED RESPECTIVELY FOR EVAL. AN MDR REPORT WITH THE FDA WAS FILED ON THIS INCIDENT BY ASPEN LABS BASED ON THE INFO PROVIDED THAT AN INJURY OCCURRED. EVAL OF THE TWO INCIDENT DEVICES BY ASPEN LABS, HAS BEEN COMPLETED AND WAS PERFORMED BY THE ASPEN LABS SERVICE MANAGER ON SITE 12/22/97 PER MUTUAL AGREEMENT. FOLLOW UP INFO STATED THERE WERE CONDITIONS NOTED WHICH INDICATED THAT THE ELECTRODE AT THE BURN SITE APPEARED TO HAVE BECOME DISLODGED OR TENTED DURING THE PROCEDURE. BOTH THE UNITS WERE TESTED AND FOUND TO BE OPERATING PROPERLY AND DELIVERING RF POWER AS EXPECTED. THE RETURN ELECTRODE ARM CIRCUITS AND ALL RF AND LOW FREQUENCY CURRENTS WERE WITH IN SPEC ON BOTH DEVICES. ALTHOUGH A DISLODGING OF THE RETURN ELECTRODE MAY HAVE CAUSED A HIGHER CURRENT CONCENTRATION AT THE DISPERSIVE SITEAND THUS CONTRIBUTED TO THIS INCIDENT, A VISUAL EXAMINATION OF THE INCIDENT RETURN ELECTRODE INDICATED A POSSIBLE CHEMICAL SPILL HAD OCCURRED AT THE PAD SITE. THERE WAS NO DEFECT IN THE ESU OR ABC UNITS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT, NO CONCLUSION CAN BE MADE FOLLOWING THEIR CHECKOUT. THIS LETTER IS THE FOLLOW UP REPORT TO YOU AS AGREED FOLLOWING THE COMPLETION OF THE CHECK OUT. ASPEN LABS REGRETS THE INCIDENT OCCURRED, HOWEVER THE DESCRIPTION INDICATED THE ORIGINAL DISPERSIVE DEVICE WHERE THE BURN OCCURRED MAY HAVE BECOME DISLODGED DURING SURGERY. THE USER IS REMINDED THAT GOOD ELECTROSURGERY PRACTICE AND THE EXCALIBUR PLUS OPERATORS MANUAL SECTION 1.1.3 CAUTIONS FOR USE, RECOMMENDS CHECKING THE DISPERSIVE ELECTRODE FOR PROPER CONTACT FOLLOWING REQUESTS FOR SIGNIFICANT INCREASES IN POWER OUTPUT, OR REPOSITIONING OF THE PT. ADDITIONALLY IT IS SUGGESTED THAT THE RETURN PAD AREA BE KEPT FREE OF ALL CHEMICALS WHICH MAY INTERFERE WITH THE CONTACT QUALITY OF THE PAD EVEN IF USING THE ARM DUAL PAD CONTACT MONITORING FEATURE OF THE MACHINES.