IGLESIAS WORKING ELEMENT

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION. THE IGLESIAS WORKING ELEMENT (EIWE), LOT NUMBER FP WAS RETURNED TO THE SERVICE CENTER FOR THE EVALUATION. THE USER¿S COMPLAINT WAS NOT CONFIRMED. A VISUAL INSPECTION WAS PERFORMED OF THE IGLESIAS WORKING ELEMENT AND IT WAS NOTED THAT CHARRED MARKS WERE INSIDE THE ACTIVE CORD INPUT SECTION AND OUTSIDE THE TEFLON PADDING AREA, WHERE THE ACTIVE CORD IS CONNECTED. THE HANDLE WAS INSPECTED AND IT WAS OBSERVED THERE WERE SMALL CHIPS. THE INSERTION WAS PORTION WAS INSPECTED AND THERE WAS NO SIGNIFICANT EXTERNAL DAMAGE NOTED. THE EIWE WAS CONNECTED TO A USG-400 GENERATOR, BY INSERTING THE DAC ACTIVE CORD TO THE EIWE WORKING ELEMENT ALONG WITH AN ELECTRODE; USING A FOOTSWITCH TO INSPECT THE FUNCTION. THE DEVICE WAS ACTIVATED AND ENERGY WAS OBSERVED TO FLOW PROPERLY WITH NO SIGNS OF SPARKING. BASED UPON THE EVALUATION OF THE IGLESIAS WORKING ELEMENT, EIWE, THE ROOT CAUSE FOR DEVICE SPARKED COULD NOT BE DETERMINED; AS THE DEVICE OPERATED NORMALLY DURING ACTIVATION AND NO SIGNS OF SPARKING OCCURRED. THE MOST PROBABLE CAUSE FOR THE SPARKING IS MOISTURE IN THE ACTIVE CORD INPUT AREA.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE SERVICE CENTER FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. UPON RETURN OF THE DEVICE, AN EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

THE SERVICE CENTER RECEIVED A REPORT OF A ROLLERBALL (RB), AND WORKING ELEMENT (EIWE)THAT SPARKED AT THE WINDOW AREA, WHITE SECTION, JUST BEFORE THE CONNECTION TO THE BALL. THIS REPORT IS FOR THE IGLESIAS WORKING ELEMENT (MODEL EIWE), LOT NUMBER FP THAT WAS USED IN THE ROLLERBALL ABLATION. THE ROLLERBALL, WORKING ELEMENT, CONNECTION POINTS TO THE GENERATOR AND DAC CABLE WERE ALL INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. THE PHYSICIAN WAS PERFORMING A THERAPEUTIC ENDOMETRIAL ABLATION WHEN THE SPARK WAS OBSERVED AT THE BEGINNING OF THE PROCEDURE. THE PHYSICIAN REMOVED THE DEVICE FROM THE SCOPE AND OBSERVED THAT THE CONNECTION POINT ON THE WORKING ELEMENT WAS CHARRED AND SMELLED LIKE ¿BURNT PLASTIC¿. THE OBSERVATION OF CHARRED MARKS AND THAT THE ROLLER BALL/BAR WAS BURNT WAS REPORTED. THE CABLE WAS DAMAGED AT THE DISTAL END OF THE RB ELECTRODE AND THE EIWE WORKING ELEMENT. IT WAS REPORTED THAT THERE WERE NO WIRES, NO EXPOSED METAL AND NO ABNORMAL OBSERVATIONS WERE NOTED PRIOR TO THE REPORTED EVENT. NO ITEMS BROKE OFF AND FELL INTO THE PATIENT. THE GENERATOR SETTING WAS NOT REPORTED AND THE CABLE WAS NOT BUNDLED. THE PHYSICIAN STOPPED THE PROCEDURE AND SWITCHED OVER TO ANOTHER TYPE OF DEVICE, NOVASURE, TO CAUTERIZE THE INSIDE OF THE PATIENT¿S UTERUS AND COMPLETED THE INTENDED PROCEDURE. IT WAS REPORTED THERE WAS NO PATIENT DEATH OR INJURY. THIS IS REPORT 2 OF 2.