{ "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 WITH LYSIS OF ADHESIONS PROCEDURE ON (B)(6) 2010 FOR MENORRHAGIA AND PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES MEDICAL NOTES AND OPERATIVE REPORTS FROM FOLLOW UP CARE. 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. SIGNIFICANT INTRA-ABDOMINAL ADHESIONS WERE ENCOUNTERED. ON (B)(6) 2010, THE PATIENT PRESENTED WITH COMPLAINTS OF URINARY LEAKING. VARIOUS STUDIES CONFIRMED THE PRESENCE OF A RIGHT URETEROVAGINAL FISTULA WITHOUT EVIDENCE OF HYDRONEPHROSIS. ON (B)(6) 2010, THE PATIENT DEVELOPED A RIGHT PYELONEPHRITIS WITH CULTURE POSITIVE FOR ENTEROCOCCUS. ON (B)(6) 2010, THE PATIENT UNDERWENT A RIGHT URETERONEOCYSTOTOMY WITH URETERAL RE-IMPLANTATION. FOLLOW UP CYSTOSCOPY WITH REMOVAL OF STENT WAS CONSIDERED NORMAL WITH NORMAL RIGHT URETERAL FUNCTION." }, { "mdr_text_key": "11243046", "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 PATIENT'S URETER INJURY IS RECOGNIZED RISK OF HYSTERECTOMY AND OFTEN OCCURS WHEN THERE IS SCAR TISSUE FROM PRIOR CESAREAN SECTION OR OTHER ANATOMIC DEVIATION. IDENTIFICATION AND PROTECTION OF THE URETER AT THIS POINT OF THE OPERATION IS ESPECIALLY CHALLENGING. 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 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": "" } ] }