{ "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 TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2010 FOR PELVIC PAIN AND MULTIPLE UTERINE LEIOMYOMA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. 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 DURING THE PROCEDURE ON (B)(6) 2010 TO REMOVE THIS 274G UTERUS WITH MULTIPLE SUBSEROSAL FIBROIDS. THE UTERINE AND OVARIAN VASCULATURE WERE TRANSECTED IN A STANDARD FASHION. AFTER DISCONNECTION OF THE UTERUS PNEUMOPERITONEUM WAS TEMPORARILY LOST. GOOD CLOSURE OF THE VAGINAL CUFF OCCURRED WITH NO BLEEDING. ESTIMATED BLOOD LOSS WAS 100ML. THE PATIENT WAS AWOKEN AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2010, THE PATIENT PRESENTED WITH MILD ILEUS AND A PARTIAL LEFT URETERAL OBSTRUCTION WITH EXTRAVASATION OF URINE INTO THE ABDOMEN. A CT SCAN SHOWED EXTRAVASATION OF URINE INTO THE ABDOMINAL CAVITY ON (B)(6) 2010. ON (B)(6) 2010, A LEFT URETERAL STENT WAS EASILY PLACED. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. SHE WAS TREATED FOR URETERAL STRICTURE ON (B)(6) 2010 WITH BALLOON DILATION AND REPLACEMENT OF HER STENT. THE PATIENT HAD A URINARY TRACT INFECTION IN (B)(6) 2010. SHE APPEARED IN GOOD HEALTH DURING AN ANNUAL EXAM IN (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER (B)(6) 2011." }, { "mdr_text_key": "11248084", "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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS 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 VINCI 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": "" } ] }