{ "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) 2011 FOR UTERINE PLACENTAL SITE TROPHOBLASTIC TUMOR. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THE INFUNDIBULOPELVIC LIGAMENT WAS ISOLATED AND THE UTERO-OVARIAN LIGAMENT WAS CAUTERIZED, AS WAS THE PROXIMAL FALLOPIAN TUBE. THE OVARIES WERE TUCKED AWAY. THE BLADDER FLAP WAS CREATED AND TAKEN DOWN WITHOUT DIFFICULTY. THE VCARE CONE BULGE WAS EASILY SEEN. AFTER REMOVAL OF THE UTERUS, THE CUFF WAS CLOSED TIGHTLY WITH SUTURE. THE PATIENT WAS BEING REVERSED AT THE TIME OF THE OPERATIVE NOTE, AND TOLERATED THE PROCEDURE WELL. SHE WAS DISCHARGED ON (B)(6) 2011 FOR A TOTAL HOSPITAL STAY OF THREE DAYS. ON (B)(6) 2011, THE PATIENT WAS ADMITTED FOR PELVIC PAIN AND A FLUID COLLECTION SUSPICIOUS FOR VAGINAL CUFF ABSCESS ON A CT SCAN. INTERVENTIONAL RADIOLOGY DRAINED SAID ABSCESS. THE VAGINAL CUFF LOOKED FINE UPON PHYSICAL EXAMINATION. SHE WAS DISCHARGED HOME ON (B)(6) 2011. NO ADDITIONAL INFORMATION IS AVAILABLE AFTER HER DISCHARGE." }, { "mdr_text_key": "11378040", "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 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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