{ "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": "2955842-2025-44952", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251114", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250301", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20251114", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "767949", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251114", "brand_name": "DA VINCI SURGICAL SYSTEM", "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": "UNKNOWN", "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": "20251121", "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": "20251114", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Death" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20251114", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23560638", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251021", "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": "385239692", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SYSTEM LOGS AND DHR COULD NOT BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. A REVIEW OF THE REPORTED ADVERSE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT AN ARTICLE ON A SERIES OF PATIENTS WHO UNDERWENT TRANS ORAL ROBOTIC SURGERY FOR HYPOPHARYNGEAL CARCINOMA REPORTED TWO DEATHS WITHIN 30 DAYS. THE AUTHORS DID NOT REPORT ANY DEVICE MALFUNCTIONS OR ISSUES RELATED TO THE DA VINCI SYSTEM THAT MAY HAVE CONTRIBUTED TO THE DEATHS. DETAILS OF THEIR PROCEDURES AND THE CAUSE OF THEIR DEATHS WERE NOT PROVIDED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT. CITATION: HAN, P., ET AL (2025). PRELIMINARY EXPERIENCE IN THE TREATMENT OF HYPOPHARYNGEAL CARCINOMA BY TRANSORAL ROBOTIC SURGERY. CHINESE JOURNAL OF OTOLARYNGOLOGY, HEAD AND NECK SURGERY, 60(3), 272¿277. HTTPS://DOI.ORG/10.3760/CMA.J.CN115330-20240803-00459. SECTION B4: SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO THE FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE IS (B)(6) 2025." }, { "mdr_text_key": "385239693", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF THE CLINICAL ARTICLE WAS CONDUCTED, WHICH SUMMARIZED THE CLINICAL EXPERIENCE AND OUTCOMES OF TRANSORAL ROBOTIC SURGERY (TORS) IN THE TREATMENT OF HYPOPHARYNGEAL CARCINOMA. THE RETROSPECTIVE MULTICENTER STUDY ANALYZED 28 PATIENTS (ALL MALE, AGED 47- 82 YEARS) UNDERGOING TRANSORAL ROBOTIC SURGERY USING THE DA VINCI SI OR XI SURGICAL SYSTEM BETWEEN SEPTEMBER 2017 AND MARCH 2024. THE ARTICLE REPORTED TWO POSTOPERATIVE DEATHS WITHIN ONE MONTH OF SURGERY WITHOUT ANY OTHER DETAILS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SURGICAL SYSTEM. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE TO THE CORRESPONDING AUTHOR, 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": "" } ] }