{ "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": "Injury", "report_number": "2955842-2018-10803", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190104", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20181114", "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": "11514", "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", " H", " 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": "8217349", "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": "132079285", "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. 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": "132079286", "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)(4) 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": "282090022", "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. HE WAS NOTED TO HAVE ¿B2 RECONSTRUCTION¿ AND ¿ANASTOMOSIS OF STOMACH POSTERIOR WALL AT GREATER CURVATURE BY FORWARD PERISTALSIS.¿ THE PATIENT HAD NOT UNDERGONE CHEMOTHERAPY OR RADIATION TREATMENT. THE PATIENT WAS REPORTEDLY ¿DOING WELL AFTER THE OPERATION¿ AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR A FEVER AT A DIFFERENT HOSPITAL. THE PATIENT WAS ADMINISTERED ANTIBIOTICS FOR AN ¿INTRAABDOMINAL ABSCESS.¿ ON AN UNSPECIFIED DATE, THE PATIENT WAS THEN TRANSFERRED TO THE SAME HOSPITAL WHERE HE HAD UNDERGONE THE DA VINCI-ASSISTED GASTRECTOMY PROCEDURE. THE PATIENT CONTINUED TO RECEIVE ANTIBIOTIC TREATMENT AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. NOTE: ISI DID NOT RECEIVE ANY INFORMATION INDICATING OR CONFIRMING THAT THE PATIENT EXPIRED AS INITIALLY SUSPECTED AND REPORTED ON THE INITIAL MDR (SUBMITTED ON 01/04/2019). 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 A POST-OPERATIVE COMPLICATION, WAS HOSPITALIZED, AND RECEIVED ANTIBIOTIC TREATMENT. HOWEVER, THE ROOT CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION IS 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" } ] }