CRYOSTAT

Description of Event or Problem

WHILE CUTTING PATIENT TISSUE THE CRYOSTAT BEGAN "CHUNKING OUT" OR CUTTING TOO DEEPLY AND TOO QUICKLY INTO THE SPECIMEN, THEREBY LEAVING THE TISSUE UNREADABLE AND NOT VIABLE. THE PROVIDER WAS IMMEDIATELY NOTIFIED AND THE "TROUBLESHOOTING" STEPS AT THE OPERATOR LEVEL WERE PERFORMED. THESE STEPS WERE DEEMED NOT HELPFUL IN RECTIFYING THE PROBLEM, AGAIN THE PROVIDER WAS NOTIFIED AND LEICA, THE MANUFACTURER WAS NOTIFIED. LEICA ARRIVED ON SITE AND SUBSTANTIATED, THAT INDEED THE MACHINE WAS NOT PERFORMING CORRECTLY AND WAS GIVING INCONSISTENT RESULTS AND BEGAN "TROUBLESHOOTING" AT THE MANUFACTURER LEVEL. AFTER SEVERAL FAILED ATTEMPTS TO CORRECT THE MACHINE, IT WAS DETERMINED THAT A NEW HEAD WAS TO BE INSTALLED IN THE MACHINE THE NEXT DAY AND THAT A "LOANER" MACHINE WOULD BE SENT OVERNIGHT FOR THE NEXT BUSINESS DAY. UNFORTUNATELY, DURING THE MACHINE MALFUNCTION, THE PATIENT'S SPECIMEN WAS DAMAGED AND NOT ABLE TO BE INTERPRETED. THIS REQUIRED ADDITIONAL TISSUE TO BE TAKEN AND SENT FOR PERMANENT SECTION. MANUFACTURER RESPONSE FOR CRYOSTAT, (BRAND NOT PROVIDED) (PER SITE REPORTER): REFER TO DESCRIPTION OF EVENT.