{ "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 S TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL URETEROLYSIS, BILATERAL LYMPHADENECTOMY , EXTENSIVE ENTEROLYSIS (LASTING OVER 4 HOURS) FOR ENDOMETRIAL CARCINOMA. PROCEDURE DATE IS UNKNOWN. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP OPERATIVE AND MEDICAL REPORTS FOR POST OPERATIVE CARE. THERE WAS NOT AN 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) 2011 THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND PURULENT DRAINAGE PER VAGINA. ON (B)(6) 2011 AN ATTEMPT WAS MADE TO DRAIN ABDOMINAL FLUID BY OPENING VAGINAL CUFF. ON (B)(6) 2011, THE PATIENT DEVELOPED FEVER THOUGHT TO BE ENTERIC-CUTANEOUS FISTULA ON (B)(6) 2011 THE PATIENT UNDERWENT REVISION OF ILEOSTOMY ON (B)(6) 2011 THE PATIENT UNDERWENT OPEN CHOLECYSTECTOMY ON (B)(6) 2011 THE PATIENT UNDERWENT EVALUATION FOR CHRONIC WOUND INFECTION. ON (B)(6) 2011 WOUND DEBRIDEMENT ON (B)(6) 2011 DISCHARGE." }, { "mdr_text_key": "11214020", "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 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 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": "" } ] }