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, THE STAGE ARM UNLATCHED DURING A BIOPSY PROCEDURE FOLLOWING THE POST-FIRE IMAGE PAIR. THE USER SITE REPORTED THAT THE STAGE ARM BEGAN REPORTING AS UNLOCKED AND STAFF WERE UNABLE TO PROCEED WITH THE PROCEDURE AS EXPOSURES WERE PREVENTED. IT WAS FURTHER REPORTED THAT THE BIOPSY NEEDLE WAS ALREADY INSERTED IN THE PATIENT¿S BREAST WHEN THE STAGE ARM LOCK RELEASED. THE USER SITE REPORTED THAT THE STAFF ATTEMPTED TO RE-LOCK THE STAGE ARM BUT THE SYSTEM DID NOT UPDATE TO A READY STATUS. THE USER SITE REPORTED THAT THE BIOPSY PROCEDURE WAS PARTIALLY COMPLETED AS THE CALCIFICATIONS WERE OBTAINED, HOWEVER VERIFICATION IMAGES FOR THE MARKER COULD NOT BE ACQUIRED. NO PATIENT INJURIES WERE REPORTED. A FIELD SERVICE ENGINEER (FSE) THE AUTHORIZED DEALER INVESTIGATED THE SYSTEM. THE FSE POWERED DOWN THE SYSTEM AND THE STAGE ARM COVERS WERE REMOVED. THE FSE REMOVED AND REPLACED THE PLUNGER, MOTOR, AND OPTICAL SENSORS ASSOCIATED WITH THE STAGE ARM DETENT MECHANISM. THE FSE ROUTED AND RECONNECTED THE CABLES TO THE CONTROL BOARD AND THE SYSTEM WAS POWERED ON. THE STAGE ARM DETENT CALIBRATION WAS PERFORMED BY THE FSE AND THE STAGE ARM WAS VERIFIED TO LOCK SECURELY AT ALL DETENT POSITIONS. THE FSE COMPLETED QUALITY ASSURANCE TESTING AND VERIFIED THAT THE NUMBERS WERE EXCEPTIONAL, AND THE FSE REPORTED THAT THE SYSTEM WAS UP AND OPERATING PROPERLY. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.