{ "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) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI RADICAL HYSTERECTOMY, URETEROLYSIS, PELVIC AND PARAAORTIC LYMPH NODE SAMPLING ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED FOLLOW-UP CONSULTATIONS, REPORTS AND RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION ON (B)(6) 2012 THE PATIENT PRESENTED WITH RIGHT SIDED PAIN, NAUSEA, VOMITING AND FEVER. THE PATIENT ALSO COMPLAINED OF VAGINAL DISCHARGE. A CT SCAN SHOWED FLUID COLLECTIONS IN THE CULDESAC WITH SIGNS OF INFLAMMATION OR INFECTION. ON (B)(6) 2012 THE PATIENT WAS ADMITTED FOR STUDIES AND TREATMENT AND WAS STARTED ON ANTIBIOTICS. ON (B)(6) 2012 THE PATIENT UNDERWENT A CYSTOSCOPY, RETROGRADE PYELOGRAM AND ATTEMPTED DOUBLE-J STENT PLACEMENT TO RULE OUT VESICOVAGINAL FISTULA, WHICH WAS NEGATIVE. A DOUBLE-J STENT COULD NOT BE PLACED; HOWEVER, AND THERE APPEARED TO BE A URETERAL OBSTRUCTION 2-3 CM CEPHALAD FROM THE BLADDER. ON (B)(6) 2012 THE PATIENT HAD A PERCUTANEOUS NEPHROSTOMY TUBE PLACED. LATER THAT DAY THE PATIENT WAS DISCHARGED ON CIPRO ANTIBIOTICS." }, { "mdr_text_key": "11395364", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. THE PATIENT HAD AN AGGRESSIVE CERVICAL CANCER WHICH WAS TREATED WITH THE ROBOTIC HYSTERECTOMY, DISSECTION OF THE URETERS AND SAMPLING OF THE LYMPH NODES. THERE WAS NO INDICATION IN THE PATIENT'S MEDICAL RECORDS OF CAUTERY OR THE USE OF THERMAL ENERGY WAS MADE. THE USUAL AND CUSTOMARY ATTEMPTS WERE MADE TO ENSURE SAFETY OF THE URETERS AT THE TIME OF THE SURGERY. THE PATIENT WAS AWARE THAT THESE TYPE OF INJURIES MIGHT OCCUR. THE PATIENT HAD APPROPRIATE FOLLOW-UP AND TREATMENT ONCE A URETERAL INJURY WAS DIAGNOSED. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SI SURGICAL PROCEDURE." } ], "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": "" } ] }