{ "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 HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY ON (B)(6) 2010 FOR MENORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORTS. 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. DURING A STANDARD HYSTERECTOMY PROCEDURE, EXCELLENT HEMOSTASIS WAS NOTED. PICTURES WERE TAKEN. NO BLADDER PERFORATIONS WERE NOTED AFTER CYSTOSCOPY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, PATIENT UNDERWENT A CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM AND STENT PLACEMENT TO REPAIR A LEFT URETERAL VAGINAL FISTULA. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN URETEROVAGINAL FISTULA AND UNDERWENT CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS, BOARI FLAP, LEFT URETERONEOCYSTOSTOMY AND INSERTION OF A LEFT URETERAL STENT. A URETEROCELE WAS NOTED IN THE RIGHT URETER AND IT WAS EASILY INTUBATED WITH A CATHETER. THE PREVIOUSLY PLACED LEFT URETERAL STENT WAS REMOVED PRIOR TO THE ABDOMINAL PROCEDURE BEING PERFORMED. AN OPEN INCISION WAS MADE AND THE LEFT URETER IDENTIFIED AND DISSECTED FREE OF SURROUNDING TISSUE. AN ADHESION OF THE URETER TO THE BLADDER WAS NOTED, AS WAS SIGNIFICANT INFLAMMATORY REACTION IN THIS AREA. THE PERITONEUM WAS ALSO ADHERED IN THIS REGION AND COULD NOT BE REMOVED. THEREFORE A SMALL RENT WAS MADE IN THE PERITONEUM FOR URETER MOBILIZATION. THIS RENT WAS CLOSED WITH AN INTERRUPTED SUTURE. MOBILIZATION OF THE BLADDER UP TO THE LEFT BLADDER FAILED FROM WITHIN THE BLADDER DUE TO PERITONEAL INFLAMMATION. THE DECISION WAS THUS MADE TO CREATE A BOARI FLAP. THE ANASTOMOSIS WAS PERFORMED SUCCESSFULLY AND THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE OPERATIVE REPORT." }, { "mdr_text_key": "11251667", "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 MEDICAL RECORDS 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 SI 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": "" } ] }