AFFIRM PRONE BIOPSY SYSTEM, 3D

Description of Event or Problem

IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2026, DURING USE OF AN AFFIRM PRONE BIOPSY SYSTEM, 3D, A TARGETING ISSUE OCCURRED DURING A BIOPSY PROCEDURE. THE USER SITE REPORTED THAT THE NEEDLE APPEARED LOW AND TO THE LEFT OF THE INTENDED TARGET. THE SITE REPEATED THE QUALITY ASSURANCE TEST, WHICH PASSED; HOWEVER, THE TARGETING CONCERN PERSISTED. A SKIN NICK HAD ALREADY BEEN MADE, AND THE PROCEDURE COULD NOT BE COMPLETED. THE PATIENT DID NOT EXPERIENCE EXCESSIVE BLEEDING OR OTHER REPORTED COMPLICATIONS, PRESSURE AND A BANDAGE WERE APPLIED, AND THE PATIENT CHOSE TO RESCHEDULE THE PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE CASE FOR AN ISOLATED ISSUE 15CM OFF IN THE X-AXIS AND DETERMINED THAT THE ISSUE APPEARED TO BE RELATED TO RETARGETING WORKFLOW, WHERE THE USER WAS RETARGETING BUT NOT MOTOR ENABLING TO THE NEWLY CREATED TARGET. TS REPORTED THAT THERE WAS NO ISSUE WITH THE SOFTWARE OR MOTOR ENABLE BUTTONS AND THAT THE EVENT WAS ATTRIBUTED TO USER TECHNIQUE RATHER THAN A DEVICE MALFUNCTION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.