AFFIRM BREAST BIOPSY GUIDANCE SYSTEM FOR SELENIA DIMENSIONS

Description of Event or Problem

IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2026, DURING A BIOPSY PROCEDURE USING THE AFFIRM BREAST BIOPSY GUIDANCE SYSTEM, A NEEDLE STRUCK THE DETECTOR, RESULTING IN A DENT IN THE DETECTOR COVER. THE SITE REPORTED THAT AN INCORRECT NEEDLE TYPE HAD BEEN SELECTED PRIOR TO DEPLOYMENT. WHEN THE NEEDLE WAS FIRED, IT CONTACTED THE DETECTOR PLATFORM, AND THE PATIENT SUSTAINED A SMALL NICK AT THE BOTTOM OF THE BREAST. IT WAS REPORTED THAT THE NEEDLE PASSED THROUGH THE PATIENT¿S BREAST. NO ADDITIONAL MEDICATION OR MEDICAL TREATMENT WAS REQUIRED, AND THE PROCEDURE WAS COMPLETED USING THE SAME NEEDLE. A HOLOGIC FIELD SERVICE ENGINEER (FSE) INSPECTED THE DEVICE AND CONFIRMED THAT THERE WAS NO DAMAGE TO THE DETECTOR. THE FSE REPLACED THE BREAST PLATFORM AND PERFORMED SYSTEM GAIN CALIBRATION AND ARTIFACT EVALUATION. THE NEW BREAST PLATFORM WAS VERIFIED BY THE FSE TO HAVE NO ISSUES. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.