{ "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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(ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA SI VINCI SURGICAL PROCEDURE. THE PATIENT'S POST OPERATIVE FINDING OF SMALL URETERAL LEAKAGE ON CT WAS TREATED WITH STENTING. THE EARLY ONSET OF SYMPTOMS DEMONSTRATE THAT URETERAL INJURY WAS LIKELY FROM DIRECT TRAUMA SUCH AS CUTTING AS OPPOSED TO CAUTERY OR THERMAL INJURY." }, { "mdr_text_key": "18797261", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP MEDICAL RECORDS FROM PRIMARY CARE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY .THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION . ON (B)(6) 2007 PATIENT PRESENTED WITH SYMPTOMS OF URINE LEAKAGE. ANTEGRADE URETERAL STENT WAS PLACED AND LEAKAGE STOPPED. PATIENT DISCHARGED HOME. SUBSEQUENT HEALTH REPORTS SHOW PROBLEMS WITH ONGOING INCONTINENCE, URETERAL STRICTURE, AND ERECTILE DYSFUNCTION." } ], "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": "" } ] }