{ "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": "Death", "report_number": "2955842-2024-20917", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241018", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240309", "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", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "AS", "manufacturer_contact_area_code": "408", "date_added": "20241019", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "991980", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241018", "brand_name": "DA VINCI", "generic_name": "DA VINCI", "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": "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": "N", "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": "US", "date_changed": "20250819", "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": "20241018", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "59 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Hemorrhage/Blood Loss/Bleeding", "Cancer", "Cardiac Arrest", "Hemorrhage/Blood Loss/Bleeding", "Cancer" ] } ], "distributor_city": "", "date_report": "20240930", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20488861", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240930", "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": "354606317", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO ADDITIONAL INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER CONCLUDED THAT BASED ON THE INFORMATION PROVIDED, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THESE EVENTS. THIS REPORT IS IN REGARDS TO A TRANSORAL ROBOTIC SURGERY CLINICAL LITERATURE ARTICLE FOR PATIENTS WITH OROPHARYNGEAL CANCER. WHILE NO ISSUES WITH THE ROBOTIC INSTRUMENTS OR EQUIPMENT ARE REPORTED, 3 PATIENTS DIED DURING THE STUDY PERIOD. ALTHOUGH THE CAUSES OF DEATH ARE LISTED ABOVE IN THE SUMMARY OF EVENTS, THE DETAILS OF HOW EACH PATIENT DIED IS NOT PROVIDED. CITATION: KORNFELD, B., TAHA, A., KYANG, L. ET AL. ONCOLOGICAL OUTCOMES POST TRANSORAL ROBOTIC SURGERY (TORS) FOR HPV-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA, A SINGLE-CENTRE RETROSPECTIVE AUSTRALIAN STUDY. J ROBOTIC SURG 18, 226 (2024). HTTPS://DOI.ORG/10.1007/S11701-024-01910-0 SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. STUDY DEMOGRAPHICS INCLUDED PATIENTS WITH A MEDIAN AGE OF 59 YEARS, THE MAJORITY (82%) OF PATIENTS WERE MALE. SECTION B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM WAS USED." }, { "mdr_text_key": "354606318", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN 2011-2022 OF 184 PATIENTS THAT UNDERWENT DA VINCI ASSISTED TORS SURGERY WITH NECK DISSECTION IN ONE SINGLE INSTITUTION, PERFORMED BY TWO TRAINED SURGEONS. THE STUDY WAS CONDUCTED TO EVALUATE THE ONCOLOGICAL OUTCOMES OF POST-TRANSORAL ROBOTIC SURGERY (TORS) FOR HPV-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA. THE 3-YEAR AND 5-YEAR DISEASE-SPECIFIC SURVIVAL WERE 98.6% (95% CI 96.7¿100%) AND 94.4% (95% CI 89.9¿99.0%), RESPECTIVELY. THREE PATIENTS DIED FROM CAUSES UNRELATED TO DISEASE RECURRENCE. ONE PATIENT (0.5%) HAD AN EARLY POSTOPERATIVE HEMORRHAGE, DEFINED BY BLEEDING OCCURRING LESS THAN 24 HOURS FOLLOWING SURGERY, RESULTING IN DEATH FOUR DAYS LATER. ONE PATIENT DIED FROM CARDIOPULMONARY ARREST; ANOTHER PATIENT DIED FROM A SECOND TUMOR METASTASIS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED." } ], "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": "" } ] }