AFFIRM PRONE BIOPSY SYSTEM

Description of Event or Problem

IT WAS REPORTED BY THE USER THAT DURING AN AFFIRM PRONE BIOPSY TABLE PROCEDURE THE USER EXPERIENCED ISSUES TARGETING THE NEEDLE. THE DEVICE "PASSED QAS THIS AM WITHOUT ISSUE [BUT] HAD A PROBLEM DURING THEIR FIRST PROCEDURE OF THE DAY, WHICH OCCURRED AT ABOUT 10:30. THE TABLE WAS INDICATING THAT THE NEEDLE WAS ADVANCED, WHEN IT WAS NOT AND WAS IN A POST-FIRE STATE, WHICH IT WAS NOT AND THAT AS A RESULT [THE USER] WAS UNABLE TO TARGET THE PATIENT AS EXPECTED. TABLE WAS REBOOTED SEVERAL TIMES WITH NO CHANGE." HOLOGIC TECHNICAL SUPPORT (TS) HELD A REMOTE TROUBLESHOOTING SESSION WITH MULTIPLE USERS AT THE CUSTOMER SITE. TS REPORTS THAT IT WAS EXPLAINED TO THE USERS THAT "ALL PICTOGRAMS ARE DISPLAYED IN THE POST FIRE POSITION AND THAT THE NEEDLE POSITION DOES NOT COMMUNICATE TO THE APB. [IT WAS] CONFIRMED WITH [THE DOCTOR] THEIR STOCK IS THE MAMMOTOME REVOLVE 12CM. HE IS REPORTING THAT HE HAD TO DIAL TO A NEGATIVE Z TO REACH THE BREAST AND MAKE A NICK IN THE SKIN. AND THAT THE BCM WAS BEEPING INDICATING THAT HE WOULD HIT THE DETECTOR WHEN HE WAS AT THE SKIN LINE. AND WHEN AT ALL GREEN ON THE DIFF LINE THE NEEDLE WAS NOT TOUCHING THE BREAST AS EXPECTED." TS FURTHER REPORTS THAT THEY "COULD NOT SEE ANY ISSUE AT THE AWS WHEN HOLDING CASE REVIEW. AND COULD NOT EXPLAIN WHY THE NEEDLE WAS NOT TOUCHING THE BREAST WHEN DIALED TO ALL GREEN." A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND WITH THE ASSISTANCE OF HOLOGIC TS, COMPLETED A "GUIDANCE HARDWARE ZERO CALIBRATION." IT IS REPORTED THAT THE FSE COMPLETED THE CALIBRATION IN ADDITION TO A "FULL STX CALIBRATION," AND THE SYSTEM IS NOW PERFORMING TO MANUFACTURER SPECIFICATIONS. THE PROCEDURE WAS ABORTED AFTER A SKIN INCISION WAS MADE ON THE PATIENT. THE PATIENT WAS RESCHEDULED FOR ANOTHER TIME. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.