{ "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": "2955842-2021-11208", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20210927", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "LITERATURE", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "", "date_added": "20210927", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1435018", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210927", "brand_name": "DA VINCI", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20210927", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "78 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20210829", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12538231", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210829", "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": "273554022", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED OPERATIVE COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SITE HISTORY COMPLAINT REVIEW WAS UNABLE TO BE CONDUCTED AT THIS TIME DUE TO LACK OF SYSTEM AND INSTRUMENT DETAIL AS WELL AS THE EVENT/PROCEDURE DATE. UNABLE TO CONDUCT SYSTEM OR INSTRUMENT LOG REVIEW DUE TO LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: PER THE CLINICAL JOURNAL ARTICLE, DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED A \"PORTAL VEIN INJURY\" AND AS A RESULT, THE CASE WAS CONVERTED TO OPEN SURGERY. IN ADDITION, THE PATIENT REPORTEDLY LOST 2540 ML OF BLOOD DURING THIS PROCEDURE. ALTHOUGH THERE IS NO ALLEGATION OR EVIDENCE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATION, THE ROOT CAUSE OF THE ALLEGED PORTAL VEIN INJURY IS UNKNOWN. IT IS ALSO UNKNOWN WHAT MEDICAL/SURGICAL INTERVENTION WAS ADMINISTERED DUE TO THE OPERATIVE COMPLICATION." }, { "mdr_text_key": "273554023", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 29-AUG-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A SCIENTIFIC REPORTS ARTICLE TITLED, ¿COMPARISON OF SHORT-TERM SURGICAL OUTCOMES USING DA VINCI S, SI AND XI SURGICAL SYSTEM FOR ROBOTIC GASTRIC CANCER SURGERY¿ (OJIMA, T., NAKAMURA, M., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI XI SURGICAL PROCEDURE WAS NOTED: A (B)(6) YEAR OLD MALE UNDERWENT A DA VINCI-ASSISTED DISTAL GASTRECTOMY PROCEDURE. THE PROCEDURE WAS CONVERTED TO OPEN DUE TO A \"PORTAL VEIN INJURY.\" IT WAS REPORTED THAT THE PATIENT LOST 2540 ML OF BLOOD DURING THIS PROCEDURE AND NO POST-OPERATIVE COMPLICATIONS OCCURRED. THE PROCEDURE WAS A TOTAL OF 598 MINUTES" } ], "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": "" } ] }