Description of Event or Problem · 0
THE CURRENT PRODUCT HAS HAD SIGNIFICANT PROBLEMS AND COMPLAINTS DURING PATIENT PROCEDURES. THE COMPLAINT RATE HAS BEEN SITTING AT OVER 30% OF PROCEDURES. THE PRODUCT HAS FAILED COUNTLESS TIMES WHEN OPERATING ON PATIENTS AND HAS RESULTED IN PRODUCT SHUTDOWN MID PROCEDURE, WITHOUT THE ABILITY TO CONTINUE. THIS HAS RESULTED IN MISDIAGNOSIS OF CANCER AND INABILITY TO GET PATIENTS THE TREATMENT THEY NEED. WE CONTINUE TO PUSH HARDER IN THE MARKET WHEN THE PRODUCT IS CLEARLY NOT READY AND I HAVE HUGE CONCERN FOR PATIENT SAFETY. I AM A YOUNGER EMPLOYEE OF (B)(6) AND NOT A VETERAN OF THE INDUSTRY AND HAVE NOT HAD A HUGE AMOUNT OF EXPERIENCE BUT I DO FEEL LIKE THIS IS A GROSS MISMANAGEMENT OF THE COMPANY AND A DISREGARD FOR WHAT IS RIGHT FOR THE PATIENT. I DO NOT KNOW WHAT THE COURSE OF ACTION IS, BUT I HOPE THAT AT LEAST AN AUDIT IS IN ORDER TO ENSURE THERE IS ACCOUNTABILITY AND THE COMPANY AND PRODUCT IS FIT TO BE USED IN PATIENTS. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".