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THE UROLOGIST HAD TO CONVERT THE ROBOTIC PROSTATECTOMY CASE TO OPEN WHEN THE SYSTEM STOPPED WORKING. THE NEXT WEEK, THE SURGEON HAD TWO ROBOTIC PROSTATECTOMIES. DURING THE FIRST CASE THERE WERE 10 ALARMS WITH THE ERROR #20013, THAT SAID PRESS FAULT OVERRIDE BUTTON. DESPITE THIS PROBLEM THE FIRST CASE WENT AS PLANNED WITHOUT ANY OTHER ISSUES. DURING THE SECOND CASE THE SAME PROBLEM WITH THE FAULT ALARM OCCURRED THREE TIMES; ON THE THIRD TIME THE FAULT DID NOT OVERRIDE. THE MANUFACTURER WAS CONTACTED USING THE DAVINCI HELP NUMBER. WE WERE INSTRUCTED TO UNDOCK THE ROBOT COMPLETELY AND POWER DOWN. I WAS INSTRUCTED TO CHECK SOME CONNECTIONS ON THE CONSOLE, WHICH WERE FINE. THEN WE TURNED ON THE ROBOT AND STARTED AGAIN. WE HAD ANOTHER FAULT THAT WE COULD NOT OVERRIDE, SO I CALLED THE COMPANY AGAIN, HAD THE SURGEON PRESS THE EMERGENCY STOP BUTTON AND THEN FAULT OVERRIDE. THIS WAS TO RELEASE THE INSTRUMENTS' GRASPS ON THE TISSUE. AT THAT TIME THERE WAS A BLEEDER THAT HADN'T FULLY GOTTEN UNDER CONTROL BECAUSE THE ROBOT WAS FROZEN. THERE WERE THREE MORE FAULTS BEFORE WE HAD ANOTHER IRRECOVERABLE FAULT. THE SURGEON DECIDED TO COMPLETELY UNDOCK THE ROBOT AND CONVERT TO AN OPEN CASE. A SALES REP CAME TO DO A SYSTEM CHECK ON THE ROBOT, AND IT SHOULD HAVE BEEN READY TO PERFORM TODAY. AFTER SPEAKING WITH THREE REPRESENTATIVES FROM THE DAVINCI COMPANY, I WAS TOLD IT WAS MOST LIKELY A COMPONENT (SENSOR) IN THE ARM THAT WAS NOT WORKING CORRECTLY. WE WERE ALSO HAVING TROUBLE WITH THE BRIGHTNESS OF THE LIGHT, BUT WE CHANGED THE LIGHT CORD AND THE PICTURE WAS NORMAL. THERE WAS SOME PROBLEM WITH OUR HARONIC AS WELL, BUT WE OPENED A NEW INSTRUMENT AND IT CONTINUED TO WORK. THE SURGEON COMPLAINED THAT ONE OF THE EYES WAS BLINKING ON AND OFF. MANUFACTURER TECHNICIAN IS SERVICING THE EQUIPMENT SHORTLY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================EQUIPMENT PROBLEMS 1. LIGHTING WAS 1/2 THE INTENSITY 2. ONE EYE WAS BLINKING OFF/ON 3. PROBLEM WITH GREEN ARM SURGEON FEELS THAT THE MACHINE KEEPS GETTING BANDAID FIXES; POOR EQUIPMENT MAINTAINANCE. THE CASE YESTERDAY THE RED ARM WOULD NOT WORK, LIGHT BULB CHANGED, BUT STILL BLINDING ON AND OFF. OUR FACILITY CONTRACTS DIRECTLY WITH MANUFACTURER FOR MAINTAINANCE WITH SERVICE AGREEMENTS.====================== MANUFACTURER RESPONSE FOR ROBOT, DA VINCI®======================MANUFACTURER WAS ON SITE FOR MAINTAINANCE; I'M WAITING FOR A REPORT. OUR FACIITY CONTRACTS WITHT THE MANUFACTURER FOR THEM TO PROVIDE THE MAINTAINANCE ON THIS PIECE OF EQUIPMENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }