{ "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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ACCORDING TO THE SURGEON'S OPERATIVE REPORT, THERE WERE ADHESIONS OF THE SMALL BOWEL TO THE ABDOMINAL WALL. LYSIS OF ADHESIONS WAS PERFORMED. THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM ON (B)(6) 2011 WITH COMPLAINTS OF ABDOMINAL DISTENTION, NAUSEA AND VOMITING. A CT SCAN OF THE PATIENT'S PELVIS WAS PERFORMED FOUND THAT THE PATIENT HAD AN ORGANIZED CLOT. A NEEDLE BIOPSY WAS PERFORMED AND NO SIGN OF ABSCESS FORMATION OR INFECTION WAS NOTED. X-RAYS PERFORMED WERE CONSISTENT WITH ILEUS. ON (B)(6) 2011 A PELVIC EXAM UNDER ANESTHESIA WAS PERFORMED. THE CUFF WAS INTACT; HOWEVER, UPON OPENING THE CUFF, FLUID CONSISTENT WITH LYSING HEMATOMA WAS DISCOVERED AND DRAINED. THERE WAS NO EVIDENCE OF FISTULA OR FOREIGN BODY, THERMAL ENERGY OR DAMAGE TO THE PATIENT'S BLADDER. FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT DID EXPERIENCE IMPROVEMENT. OVER THE COURSE OF THE PATIENT'S HOSPITALIZATION, THE PATIENT HAD CLINICALLY IMPROVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE PATIENT'S CONSULTATION REPORT INDICATED THAT SHE RETURNED TO THE HOSPITAL'S EMERGENCY ROOM ON (B)(6) 2011. A CT SCAN PERFORMED SHOWED POSSIBLE DIVERTICULITIS, URINARY INCONTINENCE AND URINARY RETENTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. BASED ON THE MEDICAL DOCUMENTATION PROVIDED THE PATIENT CONTINUED TO BE MONITORED AND TESTED FOR HER CONDITION. THERE WAS NO INDICATION THAT THE PATIENT UNDERWENT ANY ADDITIONAL SURGICAL PROCEDURE FOR HER CONDITION. THE DATE THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WAS NOT PROVIDED." }, { "mdr_text_key": "19208805", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. 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. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, 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 AFTER UNDERGOING DA VINCI SI HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMYPROCEDURE." } ], "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": "" } ] }