{ "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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IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED TORS PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED A CAROTID BLEED ON POST-OPERATIVE DAY 9 AND PASSED AWAY THE SAME DAY. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION AND SUBSEQUENT DEATH ARE UNKNOWN." }, { "mdr_text_key": "52555451", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED TRANSORAL ROBOTIC (TORS) PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED A CAROTID BLEED AND BLED TO DEATH. ON JULY 26, 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ISI WAS INFORMED OF THE PATIENT DEATH BY THE SURGEON. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2016 AND WAS UNRECORDED ON VIDEO. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE ALSO NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2016, THE CAROTID BLEED WAS IDENTIFIED AND THE PATIENT PASSED AWAY THE SAME DAY. PRIOR TO PASSING AWAY, IT IS UNKNOWN IF THE PATIENT RECEIVED ANY MEDICAL INTERVENTION DUE TO THE CAROTID BLEED. IT IS UNCLEAR AT THIS TIME IF AN AUTOPSY HAS BEEN OR WILL BE PERFORMED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }