{ "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 (B)(6), ON (B)(6) 2007, MY MOTHER HAD A DAVINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT (B)(6) MEDICAL CENTER IN (B)(6). IT IS MY UNDERSTANDING THAT DURING THIS EVENT, DR (B)(6) LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULONARY ARREST AND NEAR EXSAGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS A MAUDE ADVERSE EVENT ASSOCIATED WITH THE DAVINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN: (B)(6) MD. FACILITY: (B)(6) MEDICAL CENTER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, INCLUDING INFORMATION RELATED TO THE FIELDS IN (B)(6)." }, { "mdr_text_key": "8566169", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SITE AND PHYSICIAN'S NAME WERE NOT PROVIDED ON THE INITIAL VOLUNTARY MEDWATCH (B)(4) AND ON 04/09/2010 (B)(4) AT THE FDA WAS CONTACTED. SHE ADVISED THAT THE INITIAL REPORTER REQUESTED TO REMAIN ANONYMOUS. THE SITE AND PHYSICIAN'S NAME ALSO COULD NOT BE RELEASED. A DATABASE SEARCH WAS CONDUCTED AND A PREXISTING COMPLAINT RECORD COULD NOT BE MATCHED TO THIS REPORTED EVENT. TO THE BEST OF OUR KNOWLEDGE, INTUITIVE SURGICAL WAS NOT ADVISED OF THIS EVENT FROM THIS SITE AND AS A RESULT, THE AFFECTED DA VINCI SURGICAL SYSTEM AND/OR INSTRUMENTS AND ACCESSORIES HAVE NOT BEEN EVALUATED. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS PROVIDED A FOLLOW-UP MDR WILL BE SUBMITTED." } ], "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": "" } ] }