Description of Event or Problem · 1
INFORMANT REPORTING THAT THIS CO IS A MFR OF DEDICATED BREAST MRI SYSTEMS. WHICH ARE SILL IN THE INVESTIGATIONS STAGES. THEY HAVE NOT RECEIVED ANY 510K'S FOR THE SYSTEMS. THEY ARE PROMOTING AND ADVERTISING THEM AT TRADE SHOWS AROUND THE COUNTRY AS IF THEY HAD ALREADY BEEN APPROVED. REPORTED THAT WHEN DEVICES ARE SHIPPED TO HOSPS AND CLINICS, THEY DO NOT SHIP OPERATOR'S MANUALS WITH THEM AT THE HOSPS AND CLINICS, SO THAT THEIR WORK STATIONS CAN FOLLOW PROCEDURES FOR USE. IN THIS MANNER THEY ARE PUTTING THE PTS AT RISK FOR WRONG DIAGNOSING BY THE DRS. ACCORDING TO RPTR THE "INVESTIGATIONAL DEVICES" USED FOR DIAGNOSING BREAST CANCER SHOULD NOT BE USED BY AN IRB UNTIL THEY HAVE RECEIVED CLEARANCE BY FDA TO USE THEM. THE CO HAS RECEIVED SEVERAL COMPLAINTS ABOUT THE DEVICES, WHICH THEY HAVE NOT ADDRESSED BUT THEY PUT ASIDE WHILE THEY WAIT FOR APPROVAL BY FDA. ONE OF THE DEVICES IS A BIOPSY DEVICE AND IF IT IS NOT USED PROPERLY BY THE DRS CAN GIVE FALSE DIAGNOSES, PUTTING THE DRS AT RISK OF GIVING THEIR PTS THE WRONG DIAGNOSIS. THE CO IS NOT FOLLOWING DESIGNING CONTROL GUIDELINES OR GMP'S FOR THESE DEVICES. THE INFORMANT HAS REC'D THIS INFO FROM SOME OF THE CO'S CLIENTS, THAT HAVE COMPLAINED ABOUT THE PROBLEM TO THE MFR ALREADY ABOUT "POOR IMAGING" RESULTS.