{ "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": "I", "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": "2955842-2018-10809", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190104", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20181031", "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": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20190104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "11097", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190104", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "DA VINCI SI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/10/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20190104", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " L", " R" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Fistula", "No Code Available", "Death", "Fistula", "No Code Available" ] } ], "distributor_city": "", "date_report": "20181210", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8217455", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20181210", "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": "132079644", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE ALLEGED POST-OPERATIVE COMPLICATION SUSTAINED BY THE PATIENT. ISI HAS CONTACTED A SURGEON AT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, THE SURGEON WAS NOT WILLING TO PROVIDE ANY INFORMATION ABOUT THE CASE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2018. THE SYSTEM LOGS DO NOT SHOW ANY EVIDENCE THAT A SURGICAL PROCEDURE WAS PERFORMED ON THE DA VINCI SI SURGICAL SYSTEM IN QUESTION BASED ON THE EVENT DATE PROVIDED BY THE INITIAL REPORTER. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A PANCREATIC FISTULA/LEAK. IN ADDITION, A SURGEON INDICATED THAT THE PATIENT INVOLVED WITH THIS COMPLAINT HAD POSSIBLY EXPIRED. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT¿S POST-OPERATIVE COMPLICATION AND POSSIBLE SUBSEQUENT DEATH ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM OCCURRED." }, { "mdr_text_key": "132079685", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PANCREATIC FISTULA/LEAK. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION FROM A SURGEON AT A DIFFERENT HOSPITAL POSSIBLY RELATED TO THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT HAD POSSIBLY EXPIRED AFTER SURGERY. THE SURGEON WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS." }, { "mdr_text_key": "282089660", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 01/10/2019, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF ¿CEREBRAL INFARCTION¿ AND ¿LUNG EMPHYSEMA.¿ HE HAD NOT UNDERGONE CHEMOTHERAPY OR RADIATION TREATMENT. THE PATIENT UNDERWENT A DA VINCI-ASSISTED SURGICAL PROCEDURE ON (B)(6) 2018. ON AN UNSPECIFIED DATE POST-OPERATIVELY, A SUSPECTED INFECTIOUS PSEUDOANEURYSM WAS FOUND. ON (B)(6) 2018, BLEEDING AROUND THE DUODENUM WAS FOUND BY A CT-SCAN. IT WAS SUSPECTED THAT A RUPTURE OF THE INFECTIOUS PSEUDOANEURYSM HAD OCCURRED OR THERE WAS BLEEDING/LEAKAGE FROM A BRANCH OF THE GASTRODUODENAL ARTERY (GDA). AT THAT TIME, THE PATIENT WAS CONSCIOUS AND STABLE. ON (B)(6) 2018, THE PATIENT WAS FOUND TO HAVE DECREASED ASCITES FLUID BY A CT-SCAN AND BLEEDING HAD STOPPED. ON (B)(6) 2018 THE PATIENT¿S CONDITION ACUTELY DETERIORATED. IT WAS SUSPECTED THAT THE BLEEDING HAD REOCCURRED. THE PATIENT WAS ADMITTED TO THE ICU AND INTUBATED. THE PATIENT HAD REPORTEDLY GOTTEN BETTER BY THE EVENING TIME. ON (B)(6) 2018, THE PATIENT¿S CONDITION HAD DETERIORATED AGAIN DURING THE MORNING TIME AND IT WAS SUSPECTED THAT BLEEDING HAD REOCCURRED. THE PATIENT SUBSEQUENTLY LOST CONSCIOUSNESS AND EXPIRED. AN UNSPECIFIED DOCTOR REPORTEDLY COMMENTED, ¿INFECTIOUS PSEUDOANEURYSM WAS FORMED DUE TO POOR SUTURE¿ AND ¿HEMOPERITONEUM AND SEPSIS CAUSED BY RUPTURED PSEUDOANEURYSM LEAD TO HIS DEATH.¿ ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2018. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, A REVIEW OF THE SITE'S SURGICAL PROCEDURE HISTORY REVEALED THAT THE PATIENT HAD UNDERGONE A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENTLY EXPIRED. HOWEVER, THE ROOT CAUSES OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS ARE UNKNOWN." } ], "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": "02/08/2019" } ] }