{ "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": "2955842-2024-20754", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241022", "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": "20241022", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1817069", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241022", "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": "20250821", "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": "20241022", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "59 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Hemorrhage/Blood Loss/Bleeding", "Fistula", "Hemorrhage/Blood Loss/Bleeding" ] } ], "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": "20504524", "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": "354739591", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO 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. ADDITIONALLY, THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. 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. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H4 IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "354739592", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A STUDY TO EVALUATE THE ONCOLOGICAL OUTCOMES POST TRANSORAL ROBOTIC SURGERY (TORS) FOR HUMAN PAPILLOMAVIRUS (HPV)-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA, WAS SUMMARIZED IN A LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS ON 184 PATIENTS THAT UNDERWENT DA VINCI-ASSISTED TRANSORAL ROBOTIC SURGERY (TORS) WITH NECK DISSECTION IN ONE SINGLE INSTITUTION PERFORMED BY TWO TRAINED SURGEONS. POST-OPERATIVE TORS-RELATED COMPLICATIONS OCCURRED IN 12 PATIENTS (6.5%). NINE PATIENTS (4.9%) HAD A SECONDARY POST-OPERATIVE BLEED, DEFINED AS BLEEDING OCCURRING GREATER THAN 24 HOURS FOLLOWING SURGERY, WITH ALL PATIENTS BEING SUCCESSFULLY MANAGED EITHER CONSERVATIVELY OR WITH OPERATIVE MANAGEMENT. SALIVARY FISTULA OCCURRED IN 2 PATIENTS (1.1%). PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INSERTION FOR SWALLOWING DYSFUNCTION OCCURRED IN 10 PATIENTS (5.4%) WITH ONLY 2 PATIENTS (1.1%) REQUIRING FOR GREATER THAN 12 MONTHS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. ATTEMPTS WERE MADE TO CONTACT THE ARTICLE 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": "" } ] }