{ "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": "2955842-2018-10802", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190104", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20181128", "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": "11298", "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": "70 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": "8217337", "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": "132076184", "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 THE SURGEON 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. 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 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": "132076385", "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": "282089612", "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 DIABETES, COARCTATION OF THE RIGHT VERTEBRAL ARTERY, EMPHYSEMA, HIGH BLOOD PRESSURE, AND ALLERGIES TO MACKEREL AND CRAB. THE PATIENT WAS NOTED TO HAVE ¿B2 CONSTRUCTION¿ AND ¿ANASTOMOSIS OF STOMACH POSTERIOR WALL AT GREATER CURVATURE BY FORWARD PERISTALSIS.¿ HE HAD NOT UNDERGONE CHEMOTHERAPY OR RADIATION TREATMENT. ON (B)(6) 2018 (POST-OPERATIVE DAY #2), THE PATIENT¿S BLOOD PRESSURE HAD REPORTEDLY DROPPED DURING THE EVENING TIME AND UNSPECIFIED MEDICAL INTERVENTION WAS ADMINISTERED. THE PATIENT WAS REPORTEDLY ¿IN REMISSION.¿ HOWEVER, HIS CONDITION ¿ACUTELY DETERIORATED LATE AT NIGHT AND HE LOST CONSCIOUSNESS.¿ AROUND 11:00 PM, THE PATIENT STOPPED BREATHING DURING A CT-SCAN AND EXPIRED DESPITE THE ADMINISTRATION OF TREATMENT. THE CT-SCAN REVEALED THAT ¿MEDIASTINAL EMPHYSEMA WAS SUSPECTED¿ AND CONSIDERED ¿THE CAUSE AS THE SEPSIS FROM INFECTION BY AEROGEN.¿ THE DOCTOR DID NOT KNOW THE CAUSE OF THE PATIENT¿S DEATH. 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 CAUSES OF THE PATIENT¿S POST-OPERATIVE COMPLICATIONS AND DEATH 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" } ] }