{ "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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INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT . ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL NOTES, OPERATIVE REPORTS 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. ON (B)(6) 2012, THE PATIENT UNDERWENT ROBOTIC HYSTERECTOMY. FOLLOWING SURGERY, DEVELOPED POSTOP FEVER, ABDOMINAL DISTENTION AND INCREASING FLUID IN THE PELVIS. ON (B)(6) 2012, THE PATIENT RETURNED TO SURGERY- DIAGNOSTIC LAPAROSCOPY CONVERTED TO OPEN LAPAROTOMY WITH SMALL BOWEL RESECTION AND PRIMARY ANASTOMOSIS FOR THROUGH AND THROUGH INJURY. THE SURGEON ALSO FELT THAT A BOWEL INJURY OCCURRED DURING THE ROBOTIC HYSTERECTOMY." }, { "mdr_text_key": "11397608", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED A BOWEL INJURY." } ], "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": "" } ] }