{ "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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INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: UROLOGIC CONSULTATION (B)(6) 2011. HISTORY AND PHYSICAL (B)(6) 2011. 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. THE SURGERY WAS COMPLICATED BY A LOT OF OLD INFLAMMATORY ADHESIONS OF THE TUBES AND OVARIES BILATERALLY. THE LEFT WAS MUCH GREATER THAN THE RIGHT WITH DENSE ADHESIONS IN THE CUL-DE SAC CONSISTENT WITH OLD ENDOMETRIOSIS AND STUCK ON THE COLON. BOTH URETERS WERE IDENTIFIED. BLEEDING FROM THE RIGHT LOWER UTERINE VESSEL WAS CAUTERIZED AT THE LEVEL OF THE CERVIX. AFTER CIRCUMFERENTIAL COLPOTOMY WAS PERFORMED, THE SPECIMENS WERE DELIVERED TRANSVAGINALLY AND THE CUFF CLOSED WITH 2 QUILL 0 LATERO-MEDIAL RUNNING SUTURES. THE BLADDER WAS FILLED AND INSPECTED FOR LEAKAGE. APPLICATION OF FIBRILLAR AT THE VAGINAL CUFF AND ALONG THE SIDEWALL OF THE PELVIS WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION WITHOUT APPARENT COMPLICATIONS. THE PATIENT STARTED HAVING SOME PROBLEMS AND PRESENTED 2 WEEKS POSTOPERATIVELY ON (B)(6) 2011 WITH ABDOMINAL PAIN AND HEMATURIA. A CT ABD/PELVIS REVEALED A FLUID COLLECTION THAT WAS DRAINED WITH A PIGTAIL. ON A FOLLOW-UP CT UROGRAM A URINE EXTRAVASATION WAS NOTED AND A PERCUTANEOUS NEPHROSTOMY PLACED IN THE RIGHT URETER. AFTER ADEQUATE RECONVALESCENCE WITH ANTIBIOTIC THERAPY, RIGHT URETERAL STENT PLACEMENT AND SIGNIFICANT REDUCTION OF THE DRAINAGE VOLUME THE STENT WAS FIRST REPLACED WITH A DOUBLE-J CATHETER ON (B)(6) 2011 AND FINALLY REMOVED ON (B)(6) 2011." }, { "mdr_text_key": "11376181", "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 FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI S 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": "" } ] }