{ "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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I AM THE PERSONAL REP OF THE ESTATE OF XXX ON XX XX 2007, MY MOTHER HAS A DA VINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT XXX MEDICAL CENTER IN XXX. IT IS MY UNDERSTANDING THAT DURING THIS EVENT DR XXX LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULMONARY ARREST AND NEAR EXSANGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS AN MAUDE ADVERSE EVENT ASSOCIATED WITH THE DA VINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN XXX. MEDICAL FACILITY XXX. NO ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "8664997", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DUE TO LIMITED INFORMATION PROVIDED IN THE MAUDE EVENT REPORT (B) (4), INTUITIVE SURGICAL IS UNABLE TO PROVIDE ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED. A REVIEW OF OUR COMPLAINT DATABASE WAS PERFORMED; HOWEVER, THERE WAS NO SIMILAR EVENT FOUND RELATED TO THIS REPORT." } ], "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": "" } ] }