{ "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) 2012 FOR AN ENLARGED BOGGY UTERUS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES A HISTORY AND PHYSICAL EXAM FOR WHEN THE PATIENT DEVELOPED VAGINAL BLEEDING AFTER SURGERY. 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 PATIENT HAD AN UNEVENTFUL OPERATION. ON (B)(6) 2012, THE PATIENT CALLED THE DOCTOR'S OFFICE COMPLAINING OF A FOUL DISCHARGE. SHE BEGAN FLAGYL TREATMENT FOR A VAGINAL INFECTION. ON (B)(6) 2012, THE PATIENT WAS SEEN IN THE DOCTOR'S OFFICE WITH PAIN AND BLEEDING AFTER INTERCOURSE. SHE RETURNED TO OUTPATIENT SURGERY TO HAVE A BROKEN SUTURE REPLACED. THE UPPER VAGINA WAS RE-SUTURED WITH 5 SUTURES OF 1 VICRYL." }, { "mdr_text_key": "11372100", "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. ROOT CAUSE OF THE PATIENT'S COMPLICATION IS LIKELY DUE TO OBESITY, DIABETES, AND INFECTION, WHICH ALL DELAY WOUND HEALING. THE PATIENT HAVING INTERCOURSE PRIOR TO COMPLETE RESOLUTION OF THE INFECTION AND ALONG WITH THE DIABETES PREDISPOSED HER TO THIS TYPE OF COMPLICATION. 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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