D
Patient 1
IT WAS REPORTED THAT DURING A BIOPSY THE SYSTEM NEVER ALARMED LETTING THE TECHNOLOGIST KNOW THAT THE STROKE MARGIN SAFETY HAD BEEN EXCEEDED, AND THE NEEDLE WENT THROUGH THE PATIENT BREAST WHEN FIRED. THE TECHNOLOGIST SPOKE WITH A CLINICAL APPLICATION SPECIALIST WHO REVIEWED MULTIPLE THINGS WITH HER TO DETERMINE WHAT COULD HAVE CAUSED THE PROBLEM. ALL TESTS DONE SHOWED THE UNIT TO BE WORKING PROPERLY. A FIELD ENGINEER EVALUATED THE SYSTEM AND COMPLETED THE QUALITY CONTROL CHECK ALONE AND AGAIN WITH THE TECHNOLOGIST AND NO SYSTEM MALFUNCTION WAS FOUND. THE PLASTIC BREAST TRAY WAS REPLACED. ADDITIONAL INFORMATION RECEIVED FROM THE TECHNOLOGIST NOTED THAT THE PATIENT HAD A SMALL HEMATOMA WHICH RESOLVED ON ITS OWN AND NO MEDICAL INTERVENTION WAS NEEDED. THE BIOPSY WAS COMPLETED SUCCESSFULLY AND THERE HAVE BEEN OTHER SUCCESSFUL BIOPSIES COMPLETED WITHOUT ISSUE SINCE THIS EVENT. SHE NOTED THAT THE SYSTEM HAD BEEN "LAGGING" THAT DAY AND THE TARGET HAD TO BE SENT THREE TIMES TO BE ACCEPTED. SHE WAS UNSURE IF THIS ISSUE WAS OCCURRING WITH OTHER SYSTEMS THAT DAY OR ONLY THIS SYSTEM.