{ "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": "2955842-2024-17573", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240806", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240702", "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": "CH", "manufacturer_contact_area_code": "408", "date_added": "20240806", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20221121", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1703364", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240806", "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": "20240806", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "79 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Bacterial Infection", "Bacterial Infection" ] } ], "distributor_city": "", "date_report": "20240708", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19918033", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240708", "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": "348583506", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A REVIEW OF THE SYSTEM LOGS REVEALED NO RELATED SYSTEM ERRORS OCCURRING DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "348583507", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THREE DAYS AFTER UNDERGOING A DA VINCI-ASSISTED SIGMOID COLECTOMY FOR HIS SIGMOID CANCER, THE PATIENT EXPERIENCED AN INFECTION THAT REQUIRED ANTIBIOTIC TREATMENT AND RESULTED IN A PROLONGED HOSPITALIZATION. THE DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT INTRA-OPERATIVE COMPLICATIONS NOR DEVICE MALFUNCTIONS REPORTED. A THIRD-PARTY 28MM GASTROINTESTINAL STAPLER WAS USED FOR THE END-TO-END ANASTOMOSIS PERFORMED DURING THE PROCEDURE. THREE DAYS LATER, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND A CT-SCAN SHOWED AN ABDOMINAL INFECTION AND THE PATIENT REQUIRED CHANGE OF ANTIBIOTIC REGIMEN WHICH CEFUROXIME WAS SWITCHED TO MEROPENEM, AND INTRAMUSCULAR TRAMADOL. THE STUDY PHYSICIAN BELIEVED THE CAUSE OF THE INFECTION IS RELATED TO PATIENT'S CONDITION OF INCOMPLETE OBSTRUCTION OF THE SIGMOID COLON, INTUSSUSCEPTION AND EXCESSIVE STOOL PRE-OPERATIVELY, AS WELL AS POSSIBILITY OF ANASTOMOTIC LEAKAGE CAUSED BY EXCESSIVE STOOL INFECTION. THE STUDY INVESTIGATOR CONSIDERED THE EVENT AS NOT RELATED TO THE PROCEDURE NOR THE DEVICES." } ], "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": "" } ] }