{ "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 TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2010 FOR FIBROIDS WITH MENORRHAGIA AND FAILED PREVIOUS NOVASURE. ISI 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 A REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PROCEDURE WAS UNREMARKABLE. THE BLADDER WAS DENSELY ADHERED TO THE LOWER LINING OF THE UTERINE SEGMENT FROM A PREVIOUS CAESARIAN SECTION. NONETHELESS THE CORRECT PLANE WAS IDENTIFIED AND THE BLADDER DISSECTED SAFELY OFF. THE COLPOTOMY WAS PERFORMED AND THE VAGINA CLOSED UNEVENTFULLY. THE PATIENT WAS AWOKEN AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. SHE WAS DISCHARGED THE FOLLOWING DAY FOR A TOTAL STAY OF 2 DAYS. ON (B)(6) 2010, SHE PRESENTED TO THE ER WITH SEVERE LOWER ABDOMINAL PAIN AND CRAMPING. A CT SCAN REVEALED A LARGE AMOUNT OF STOOL IN HER COLON. ON (B)(6) 2010, SHE PRESENTED WITH PERITONITIS AND ON (B)(6) 2010 UNDERWENT AN EXPLORATORY LAPAROTOMY THAT INCLUDED THE LYSIS OF MULTIPLE BOWEL ADHESIONS, AN ABDOMINAL WASHOUT, THE PLACEMENT OF PERITONEAL DRAINS FOR AN ABSCESS AND AN APPENDECTOMY. A CYSTOSCOPY WAS PERFORMED AND URETERAL REANASTOMOSIS AND REIMPLANTATION OCCURRED AFTER INDIGO CARMINE FAILED TO EXIT FROM THE RIGHT URETER. A STENT WAS PLACED. NO ADDITIONAL INFORMATION IS AVAILABLE AFTER THIS PROCEDURE." }, { "mdr_text_key": "11253112", "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. 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": "" } ] }