THE WORKING ELEMENT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, BASED ON SIMILAR REPORTED EVENTS THE MOST PROBABLE CAUSE CAN BE ATTRIBUTED TO THE DEBRIS OR FLUID INSIDE THE ACTUATION BLOCK OF THE WORKING ELEMENT OR THE CORRESPONDING ELECTRODE IS NOT CONNECTED PROPERLY INSIDE THE ACTUATION BLOCK WHICH CAN CAUSE ARCING. IF THE DEVICE IS RETURNED FOR EVALUATION AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. THE INSTRUCTION MANUAL WARNS USERS ?INTRODUCE A NEW PLASMAKINETIC SUPERSECT/LOOP DEVICE AND THE INSTRUMENT CABLE INTO THE STERILE FIELD. INSERT THE T-SHAPED CONNECTOR ON THE INSTRUMENT CABLE INTO THE SLOT ON THE BASE OF THE WHITE INSTRUMENT MOUNTING BLOCK. ENSURE THAT THE CONNECTOR IS FULLY SEATED WITHIN THE BLOCK.? IN ADDITION, THE OEM HAS ATTRIBUTED THIS TYPE OF PHENOMENON TO FLUIDS INVADING THE CONNECTION BLOCK CAUSING AN ELECTRICAL SHORT TO OCCUR DUE TO THE POOR CONNECTION OF THE ELECTRODE, WORKING ELEMENT AND CABLE.
D
Patient 1
OLYMPUS WAS INFORMED THAT DURING SET-UP OF AN ENDOMETRIAL ABLATION PROCEDURE, A BIG SPARK OCCURRED WHEN THE DOCTOR WAS CONNECTING THE ACTIVE CORD TO THE WORKING ELEMENT. THE SPARK WAS OBSERVED AT THE CONNECTION OF THE TWO DEVICES. BOTH DEVICES WERE REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED WITH SIMILAR DEVICES WITHOUT ISSUE. IT IS UNKNOWN IF THE GENERATOR WAS ON OR IF THE CABLE WAS CONNECTED TO THE GENERATOR DURING THE SPARK. THE WORKING ELEMENT WAS INSPECTED PRIOR TO SET-UP WITH NO ANOMALIES AS THE SINGLE USE ACTIVE CORD WAS BRAND NEW. BOTH DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION. 1 OF 2 DEVICES.