{ "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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RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT ROBOTIC HYSTERECTOMY FOR FIBROID UTERUS ON (B)(6) 2012 AND WAS REPORTED TO HAVE DEVELOPED POST-OPERATIVE COMPLICATIONS. THE PATIENT UNDERWENT THE ROBOTIC ASSISTED HYSTERECTOMY ON (B)(6) 2012, WITH A MEDICALLY MANAGEABLE POST-OPERATIVE RECOVERY AND WAS DISCHARGED FROM HOSPITAL ON POST-OPERATIVE DAY 2 ((B)(6) 2012). FOLLOWING THE ROBOTIC-ASSISTED HYSTERECTOMY,THE PATIENT UNDERWENT ELECTIVE VESICOVAGINAL FISTULA REPAIR ON (B)(6) 2012. THE PATIENT WAS DISCHARGED ON (B)(6) 2012, WITH A FOLEY CATHETER TO MANAGE THE HEALING OF THE VESICOVAGINAL REPAIR. THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2012, WITH COMPLAINTS OF ABDOMINAL PAIN AND HEMATURIA WITH CLOTS. PER THE MEDICAL RECORDS, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM ON (B)(6) 2012, FOR OPEN RETROPERITONEAL REPAIR OF THE VESICOVAGINAL FISTULA, REVISION OF THE VAGINAL CUFF AND CYSTOSCOPY. PROCEDURE WENT AS PLANNED WITHOUT ANY COMPLICATIONS. DURING THE POST-OPERATIVE RECOVERY PHASE, THE PATIENT DEVELOPED ABDOMINAL/FLANK AND RIGHT LEG HYPERESTHESIAS. THE PATIENT WAS TREATED WITH PAIN MEDICATION AND PHYSICAL THERAPY. THE PATIENT WAS DISCHARGED ON (B)(6) 2012 AND WAS ADVISED TO FOLLOW UP WITH HER PHYSICIAN. NO ADDITIONAL INFORMATION HAS BEEN AVAILABLE SINCE THEN." }, { "mdr_text_key": "17095488", "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 A DA VINCI SI SURGICAL HYSTERECTOMY 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": "" } ] }