{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2955842-2015-01349", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20151030", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20060814", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20151030", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "721784", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151030", "brand_name": "DA VINCI S SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250819", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20151030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " L", " R" ], "patient_age": "75", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Laceration(s)", "Sepsis" ] } ], "distributor_city": "", "date_report": "20151001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5192243", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20151001", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "29994124", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO ALLEGATION BASED ON THE OPERATIVE REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A INTRA-OPERATIVE COMPLICATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE AND PASSED AWAY ON POST-OPERATIVE DAY 4. HOWEVER, THE CAUSES OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE ARE UNKNOWN." }, { "mdr_text_key": "29994125", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 10/01/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5056296 WITH THE FOLLOWING EVENT DESCRIPTION: THIS IS A LATE REPORT AS WE WERE UNAWARE WE COULD HAVE REPORTED EARLIER TO FDA. MY MOTHER, (B)(6), AT TIME OF DEATH, WAS UNDERGOING A MITRAL VALUE [SIC] REPAIR WITH THE SURGEON, DR. (B)(6), USING THE DAVINCI ROBOT. THIS OCCURRED AT (B)(6) ON (B)(6) 2006. ACCORDING TO THE PHYSICIAN, THE ROBOT NICKED HER HEART WHICH RESULTED IN BLEEDING OUT AND EMERGENCY OPEN HEART SURGERY. SHE NEVER RECOVERED AND DEVELOPED SEPSIS INFECTION 4 DAYS LATER. WE WERE INFORMED LATER THAT OUR MOM WAS THE ONLY THE 3RD PATIENT FOR HEART VALVE SURGERY ON THIS ROBOT. WE ALSO ARE AWARE THAT ANOTHER WOMAN DIED SUBSEQUENTLY BY THE SAME ROBOT AND PHYSICIAN. THE DOCTOR LEFT TOWN AFTER THIS. (WE NEVER FILED A LAWSUIT DUE TO (B)(6) LAWS ON DAMAGES.) I AM WRITING THIS TO INFORM THE FDA AND TO NOTIFY YOU OF AN ADVERSE EVENT FOR YOUR STATS OF THIS DAVINCI ROBOT. MY HOPE IS THAT NO ONE WILL HAVE TO DIE FROM THIS ROBOT IN THE FUTURE IN THE CARDIAC REALM OF USE FOR DAVINCI. THANK YOU. (B)(6). ON 10/02/2015, ISI CONTACTED THE INITIAL REPORTER (THE PATIENT'S DAUGHTER) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS LONG AND THE SURGEON REPORTEDLY INFORMED HER THAT THE ROBOT NICKED THE PATIENT'S HEART. HOWEVER, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE INJURY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INFORMED HER THAT A SUCKER MECHANISM WAS INVOLVED WITH THE PATIENT'S INTRA-OPERATIVE COMPLICATION. THE INITIAL REPORTER STATED THAT THE PATIENT BLED A LOT AND THE PATIENT NEVER REGAINED CONSCIOUSNESS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT PASSED AWAY ON (B)(6) 2006. THE CAUSE OF DEATH PER THE DEATH CERTIFICATE WAS SEPSIS. ON 10/13/2015 AND 10/23/2015, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL WHERE THE DA VINCI MITRAL VALVE REPAIR PROCEDURE WAS PERFORMED. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. THE RISK MANAGER ALSO COULD NOT FIND A DEFINITIVE CAUSE OF THE INTRA-OPERATIVE COMPLICATION. PER THE OPERATIVE REPORT, THE INTRA-OPERATIVE COMPLICATION WAS FOUND AFTER THE ROBOT HAD BEEN UNDOCKED FROM THE PATIENT. AFTER UNDOCKING THE ROBOT, THE PATIENT WAS PLACED IN TRENDELENBURG POSITION AND DE-AIRED WHILE SUCTION DEVICES REMAINED IN PLACE. DURING THE DE-AIRING PROCESS, A SMALL HOLE WAS FOUND ON THE LEFT ATRIAL APPENDAGE. THE HEART DEFECT WAS REPAIRED WITH STAPLES. THE RISK MANAGER DID NOT KNOW IF THE INTRA-OPERATIVE COMPLICATION OCCURRED DURING THE TIME THE ROBOT WAS DOCKED TO THE PATIENT OR AFTER THE ROBOT WAS UNDOCKED. THE RISK MANAGER INDICATED THAT THE PATIENT HAD SEVERAL COMORBIDITIES INCLUDING MYASTHENIA GRAVIS AND HYPERGLYCEMIA. THE RISK MANAGER WAS UNABLE TO CONFIRM FROM THE PATIENT'S MEDICAL RECORDS IF THE PATIENT PASSED AWAY FROM SEPSIS AS REPORTED BY THE INITIAL REPORTER. SHE WAS ALSO UNABLE TO CONFIRM IF THE PATIENT'S DEATH WAS RELATED TO THE INTRA-OPERATIVE COMPLICATION AND/OR THE DA VINCI SURGICAL PROCEDURE. THE RISK MANAGER DID NOT HAVE THE PATIENT'S DEATH CERTIFICATE. ACCORDING TO THE RISK MANAGER, THE CAUSE OF DEATH APPEARED TO BE INCONCLUSIVE PER THE DISCHARGE SUMMARY." } ], "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": "" } ] }