{ "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": "2955842-2024-18506", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240827", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240621", "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", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20240827", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211012", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "940554", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240827", "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": "20250820", "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": "20240827", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "57 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Abscess", "Unspecified Infection", "Abscess", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20240731", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20077537", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240731", "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": "350302949", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME." }, { "mdr_text_key": "350302950", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, AN ABDOMINAL SURGICAL WOUND INFECTION WAS IDENTIFIED 22 DAYS POST-OPERATIVELY. THE NURSE OBSERVED REDNESS, SWELLING, HEAT, AND PAIN AROUND THE WOUND. THE RESIDENT PHYSICIAN EXAMINED THE WOUND, REMOVED ONE STITCH, AND EXPRESSED A LARGE AMOUNT OF FOUL-SMELLING PUS. A WOUND CULTURE WAS TAKEN, AND INSTRUCTIONS WERE GIVEN FOR WOUND PACKING AND DRAINAGE CARE EVERY 8 HOURS. BLOOD TESTS WERE SCHEDULED, AND A BLOOD CULTURE WAS PERFORMED. THE NEXT DAY, A DRAINAGE TUBE WAS PLACED IN THE LEFT ABDOMEN TO DRAIN AN ABDOMINAL ABSCESS. ONE WEEK LATER, THE LEFT ABDOMINAL DRAINAGE TUBE (DRAINAGE FLUID <2ML) WAS REMOVED. THE ATTENDING PHYSICIAN EXAMINED THE SUBJECT AND THE ABDOMINAL WOUND, AND IT WAS NOTED THAT THE SUBJECT COULD BE DISCHARGED IN 2-3 DAYS WITH CONTINUED OBSERVATION. ONE WEEK LATER, THE PATIENT WAS IN GOOD SPIRITS AND WITH GOOD ENERGY. THE WOUND IN THE RIGHT ABDOMEN HAD HEALED WITHOUT FURTHER PUS FORMATION, AND THERE WAS NO FEVER, SO DISCHARGE WAS APPROVED FOR THE SAME DAY. THERE IS NO REPORT THAT A DA VINCI DEVICE MALFUNCTIONED OR CAUSED OR CONTRIBUTED TO THE EVENT." } ], "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": "" } ] }