Description of Event or Problem · 1
AFTER THE FINESSE BIOPSY DEVICE WAS UTILIZED FOR THE FIRST BIOPSY SAMPLE (WITH THE DEVICE ORIENTED AT THE 12 O'CLOCK POSITION), IT WAS NOTED THAT THE BREAST MASS STRUCTURE COMPLETELY COLLAPSED, HOWEVER, NO DEFINITE TISSUE WAS IDENTIFIED WITHIN THE COLLECTION CHAMBER. IT WAS FELT THAT THIS MAY HAVE BEEN A FLUID FILLED DUCT WITH FLUID BENEATH THE COLLECTION CHAMBER, NOT AN UNCOMMON OCCURRENCE WHEN UTILIZING THIS DEVICE. THEREFORE, THE BIOPSY DEVICE WAS THEN TURNED TO THE APPROXIMATE 3 O'CLOCK POSITION. THE DEVICE WAS FIRED WITH THE CUTTING CHAMBER NOTED TO COURSE THROUGH THE BIOPSIED REGION, HOWEVER, NO DEFINITE TISSUE WAS IDENTIFIED IN THE COLLECTION CHAMBER. AN ADDITIONAL ATTEMPT WAS MADE AT OBTAINING TISSUE WITH THE DEVICE ORIENTED AT THE 6 O'CLOCK POSITION, HOWEVER, NO TISSUE WAS WITHIN THE COLLECTION CHAMBER. THEREFORE, THE FINESSE BIOPSY DEVICE WAS REMOVED LEAVING THE INTRODUCER IN PLACE. THE NURSE WAS GIVEN THE FINESSE BIOPSY DEVICE IN ORDER TO TRY TO RETRIEVE THE TISSUE BY RETRACTING THE NEEDLE TO REVEAL THE CUTTING TROUGH, HOWEVER, THE TROUGH WAS NOTED TO NOT BE PRESENT. THE INTRODUCER WAS REMOVED AND PLACED ON THE STERILE TRAY. AT THE CONCLUSION OF THE BIOPSIES, SALINE WAS FLUSHED THROUGH THE FINESSE INTRODUCER CHAMBER WHILE OVER THE SAME FORMALIN CONTAINER WHICH HAD THE SAMPLES OBTAINED WITH THE MAXCORE DEVICE. THREE LARGE CORE BIOPSY SAMPLES WERE VISUALIZED DROPPING INTO THE FORMALIN CONTAINER IN ADDITION TO AN APPROXIMATE 1.5 INCH METAL PIECE. THIS PIECE WAS REMOVED FROM THE FORMALIN CONTAINER WITH STERILE FORCEPS. THE BIOPSY DEVICE WAS EXAMINED BOTH BY NURSE AND DOCTOR; THE FREE METAL PIECE WAS IDENTIFIED AS BEING PART OF THE CUTTING DEVICE/TROUGH FROM THE FINESSE DEVICE. THIS PIECE WAS FREE FROM ANY OF THE CORE SPECIMENS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ULTRASOUND GUIDED CORE BIOPSIES OF THE BREAST.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.