{ "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 PROCEDURE ON (B)(6) 2013 FOR UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, FOLLOW-UP OPERATIVE REPORTS AND DOCUMENTATION REGARDING URETERAL INJURY. 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 THE DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2013, PATIENT PRESENTED WITH SYMPTOMS OF ABDOMINAL PAIN AND UNDERWENT A CT SCAN WHICH DEMONSTRATED PARTIAL URETERAL OBSTRUCTION. ON (B)(6) 2013, THE PATIENT UNDERWENT A CYSTOSCOPY WITH PASSAGE OF A STENT. A PARTIAL TRANSECTION OF THE URETER IS SUSPECTED. A URETERAL RE-IMPLANTATION IS PLANNED. NO OTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "17362845", "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 REPORT FOR THE DA VINCI SURGICAL PROCEDURE DETAILS USE OF BOTH MONOPOLAR AND BIPOLAR ENERGY WITH PK FORCEPS TO COAGULATE AND TRANSECT ALMOST ALL PEDICLES. INJURY TO THE DISTAL URETER IS A RECOGNIZED COMPLICATION WITH ANY TYPE OF HYSTERECTOMY AND IS AN ACCEPTED RISK OF THE PROCEDURE. 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. 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