{ "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 WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, RESECTION OF ENDOMETRIOSIS AND CYSTOSCOPY ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE (OP) REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED FOLLOW-UP HOSPITAL RECOVERY NOTES: ACCORDING TO THE INFORMATION IN THE PATIENT'S OP REPORT, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 THE PATIENT PRESENTED TO THE ER WITH ABDOMINAL PAIN, VAGINAL BLEEDING, AND REPORTS OF FEVER. THE PATIENT WAS GIVEN PACKED RED BLOOD CELLS TRANSFUSION. NOTES FROM THE HOSPITAL REPORT THAT THE PATIENT WAS AFEBRILE ON MULTIPLE DETERMINATIONS. A CT SCAN SHOWED 7/8CM PELVIC FLUID COLLECTION POSSIBLY RESOLVING A HEMATOMA. THE PATIENT'S COMPLETE BLOOD COUNT SHOWED THAT THE PATIENT HAD A NORMAL WHITE BLOOD COUNT AND HEMATOCRIT. THE PATIENT WAS TREATED WITH IV UNASYN DESPITE LACK OF EVIDENCE OF INFECTION OR DOCUMENTED FEVER. THE PATIENT WAS DISCHARGED TO HOME ON PERCOCET AND AUGMENTIN." }, { "mdr_text_key": "17774503", "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. IT HAS BEEN DETERMINED THAT THERE WAS NO ADVERSE EVENT RELATED TO THE DA VINCI SURGICAL SYSTEM FOUND IN THIS CASE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. 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 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": "" } ] }