{ "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 FOR SYMPTOMATIC UTERINE FIBROIDS ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE AND RADIOLOGY 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. AT THE TIME OF ROBOTIC HYSTERECTOMY THE PATIENT WAS NOTED TO HAVE EXTENSIVE LYSIS OF ADHESIONS ALONG WITH BSO. SHE WAS DISCHARGED HOME IN STABLE CONDITION THE NEXT DAY. ON (B)(6) 2010 THE PATIENT DEVELOPED SOME INCONTINENCE SHE UNDERWENT CYSTOSCOPY WHICH NOTED A FILLING DEFECT AND THEN AFTER WORSENING INCONTINENCE, A VESICOVAGINAL FISTULA WAS DIAGNOSED. ON (B)(6) 2010 UNDERWENT AN OPEN LAPAROTOMY WITH EXCISION OF THE FISTULA AND CLOSURE AND THE APPLICATION OF AN OMENTAL FLAP INTERPOSITION GRAFT." }, { "mdr_text_key": "11251721", "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 SI SURGICAL PROCEDURE. VESICOVAGINAL FISTULA IS A RECOGNIZED COMPLICATION OF HYSTERECTOMY AND MAY OCCUR WITH ANY OPERATIVE TECHNIQUE. THE RISK OF SUCH INJURY IS AT AN ACCEPTABLE RATE BUT MAY BE HIGHER IN THE PRESENCE OF PELVIC ADHESIONS AS HAPPENED IN THIS CASE. FOR THIS PATIENT, IT WAS REPAIRED SUCCESSFULLY IN A TIMELY WAY." } ], "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": "" } ] }