{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S PROCEDURE HISTORY. ACCORDING TO SURGEON'S AND SITE'S PROCEDURE HISTORY, THERE IS NO RECORD THAT THE SURGEON PERFORMED A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2008 AS REPORTED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT CLAIMED THAT HE EXPERIENCED PERMANENT DAMAGE RELATED TO INCONTINENCE AND IMPOTENCY. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE ALLEGED POST-OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "62527159", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 11/16/2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5065724 WITH THE FOLLOWING EVENT DESCRIPTION: I LIKE SCORES OF OTHER CLINIC PATIENTS, WAS PERMANENTLY HARMED WITH DAVINCI ROBOT. ALTHOUGH I WAS GIVEN 5500 CC OF COLLOIDS AND CRYSTALLOID DURING MY SURGERY, THE COPY AND PASTE OF OP NOTE REPORTED 150 CC BLOOD LOSS AND NO COMPLICATIONS. STATED HE HAD TROUBLE, COULD NOT SEE ANYTHING, USED A TEMPLATE, HAD TO GUESS LEAVING ANASTOMOSIS, BACTEREMIA, PEYRONIE'S DISEASE, IMPOTENT, AND TOTALLY INCONTINENT. THE GENERIC OP REPORT STATES, NO COMPLICATIONS. MY BLADDER WAS STAPLED INSTEAD OF THE FINE BASEBALL STITCHING: ADVERTISED BY THE SURGEON. A PERMANENTLY HARMED PT., INFORMED ME THAT WE WERE TEST SUBJECTS WITHOUT OUR CONSENT, BEFORE HE WAS SILENCED WITH A PAYOFF BY THE CLINIC. THE CLINIC REFUSED TO PROVIDE ME SERIAL NUMBER OR DESCRIBE THE DA VINCI FAILURES WHICH CAUSED MY HARM. I LOST MY JOB AS A (B)(6) PILOT. I AM NOW DISABLED AND IN CONSTANT PAIN. ON 12/05/2016, ISI CONTACTED THE PATIENT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ON (B)(6) 2008, THE PATIENT UNDERWENT A DA VINCI-ASSISTED RADICAL PROSTATECTOMY AND WAS ALLEGEDLY LEFT DISABLED WITH PERMANENT DAMAGE OF INCONTINENCE AND IMPOTENCY. AS PER THE PATIENT, HE CLAIMED THAT HE COULD NOT MOVE FOR 3 DAYS POST-OPERATIVELY. HE ALSO CLAIMED THAT HE LOST 2000 CC OF BLOOD, AND WAS GIVEN 6000 CC OF IV FLUIDS AND EXPANDERS SUCH AS COLLOIDS. THE PATIENT INDICATED THAT HE CONTINUED TO BLEED POST-OPERATIVELY AND IT WAS AN ANASTOMOTIC LEAK. WHEN THE PATIENT RETURNED TO THE HOSPITAL TO HAVE HIS TUBES AND CATHETER REMOVED, HE REPORTEDLY DID NOT SEE THE SURGEON. SIX WEEKS POST-OPERATIVELY, THE PATIENT CLAIMED THAT HE HAD SEVERE NIGHT SWEATS. THE PATIENT ALSO STATED THAT HE REFUSED TO LET ANOTHER SURGEON ASSIST HIM AND JUST ALLOWED THE ANASTOMOTIC LEAK TO TAKE ITS OWN COURSE. ACCORDING TO THE PATIENT, THE ANASTOMOTIC LEAK RESOLVED WITHIN TWO MONTHS WITHOUT ANY INTERVENTION. ON 12/06/2016, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR TO GATHER ADDITIONAL INFORMATION. THE ROBOTICS COORDINATOR INDICATED THAT THE SITE DOES NOT HAVE ANY RECORDS RELATED TO THE REPORTED EVENT." } ], "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": "" } ] }