AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Description of Event or Problem

IT WAS REPORTED ON (B)(6) 2026, DURING AN AFFIRM BREAST BIOPSY SYSTEM PROCEDURE, THE (DEVICE) DOESN'T SEEM LIKE IT IS MOVING TO OUR TARGET CORRECTLY. DURING THE SECOND BIOPSY PROCEDURE, A SKIN NICK WAS MADE AND THE NEEDLE WAS INSERTED; HOWEVER, A PRE-FIRE IMAGE DEMONSTRATED THAT THE NEEDLE TRAJECTORY WAS NOT ALIGNED WITH THE INTENDED TARGET DESPITE THE TARGET REMAINING OVER THE LESION. THE RADIOLOGIST ELECTED TO ABORT THE PROCEDURE AND RESCHEDULE THE BIOPSY PENDING SERVICE EVALUATION. NO COMPLICATIONS WERE REPORTED FROM THE SKIN NICK, AND THE PATIENT WAS DISCHARGED AND WILL BE RESCHEDULED AT A LATER DATE. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE DEVICE. THE FSE DOCUMENTED THAT THE SITE HAD RECENTLY IMPLEMENTED NEW BIOPSY NEEDLES THAT HAD NOT BEEN VALIDATED USING THE TARGETING PHANTOM PRIOR TO THE PROCEDURES. THE CUSTOMER PLANNED TO REVIEW NEEDLE APPLICATION AND COMPLETE TARGETING PHANTOM VALIDATION WITH THE NEEDLE VENDOR AND APPLICATIONS SUPPORT. FOLLOWING SERVICE REVIEW, THE SYSTEM WAS REPORTED TO BE OPERATING WITHIN MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.