{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2025-16326", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250501", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250403", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250501", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230306", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2422805", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250501", "brand_name": "DA VINCI SP", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-45", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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": "US", "date_changed": "20250825", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20250501", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20250403", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21946182", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250403", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "369396453", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION." }, { "mdr_text_key": "369396454", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY DUE TO BLEEDING FROM THE ACCESSORY RIGHT COLIC VEIN WHICH WAS CAUSED BY FORCE BEING APPLIED WHEN LIFTING THE INTESTINES THROUGH A SMALL INCISION. THE PATIENT, DIAGNOSED WITH ADVANCED CANCER AND LYMPH NODE ENLARGEMENT, INITIALLY HAD A SURGICAL PLAN INVOLVING THE UNDOCKING OF THE SP SYSTEM, FOLLOWED BY THE PLACEMENT OF AN ACCESS PORT KIT AND THE ELEVATION OF THE INTESTINES THROUGH A SMALL INCISION FOR A SEMI-OPEN (HYBRID) PROCEDURE. HOWEVER, AFTER TREATING THE ILEOCOLIC ARTERY (ICA) AND ILEOCOLIC VEIN (ICV), DIFFICULTIES AROSE DURING DISSECTION AROUND THE SURGICAL TRUNK, LEAVING THE SUPERIOR MESENTERIC VEIN (SMV) AND ACCESSORY RIGHT COLIC VEIN UNTREATED. THE SURGEON EXPLAINED THAT UPON REMOVAL OF THE DA VINCI SP PORT AND WHILE ATTEMPTING TO PROCEED WITH THE SEMI-OPEN OPERATION, THE \"EXTERNAL PASSIVE FORCE\" WAS INADEQUATE. THIS INADEQUACY LED TO EXCESSIVE FORCE BEING APPLIED WHEN LIFTING THE INTESTINES THROUGH THE SMALL INCISION, CAUSING INJURY TO THE ACCESSORY RIGHT COLIC VEIN. THE RESULTING INJURY LED TO SIGNIFICANT BLEEDING, WITH AN ESTIMATED BLOOD LOSS OF 4000 ML, AND THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE PROCEDURE WAS THEN CONVERTED TO AN OPEN APPROACH, AND HEMOSTASIS WAS ACHIEVED BY A CARDIAC SURGEON WHO REPAIRED THE INJURY WITH SUTURES. THE PROCEDURE WAS COMPLETED, AND THE PATIENT SPENT 6 DAYS IN THE INTENSIVE CARE UNIT (ICU) BEFORE BEING TRANSFERRED TO THE GENERAL WARD. SINCE THEN, THERE HAVE BEEN NO SPECIFIC ISSUES, AND THE POSTOPERATIVE COURSE HAS BEEN PROGRESSING WELL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }