{ "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 WITH BILATERAL SALPINGO-OOPHORECTOMY FOR UTERINE FIBROIDS AND ENDOMETRIOSIS ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. 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. THE OPERATIVE NOTE STATES THAT THERE WERE EXTENSIVE ADHESIONS POSTERIORLY AND THAT THERE WAS POOR VISUALIZATION POSTERIORLY. SHE UNDERWENT A DIFFICULT HYSTERECTOMY DUE TO ENDOMETRIOSIS. SHE BECAME ANURIC POSTOPERATIVELY. THE CT SCAN DEMONSTRATED BILATERAL URETERAL OBSTRUCTION. IN THE OR THE URETERS WERE FOUND TO BE OBSTRUCTED AT THE VAGINAL CUFF AND POSTERIOR BLADDER. A BILATERAL URETERAL REIMPLANTATION WAS PERFORMED SUCCESSFULLY. THE STENTS WERE REMOVED ON (B)(6) 2012." }, { "mdr_text_key": "15975945", "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 INJURY SUSTAINED 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. 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