{ "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": "2955842-2026-30031", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260702", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250826", "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", "Study", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20260702", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "615756", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260702", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "UNKNOWN", "catalog_number": "UNKNOWN", "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" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260702", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "68 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dehydration", "Hematoma", "Altered State of Consciousness" ] } ], "distributor_city": "", "date_report": "20260605", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25691028", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260605", "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": "406281401", "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. NO IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE REVIEWED. DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, THE PUBLICATION DATE HAS BEEN USED AS THE EVENT DATE. VERIFICATION OF THE EVENT DETAILS CANNOT BE PERFORMED AT THIS TIME DUE TO INSUFFICIENT EVENT DATE INFORMATION. THE PROCEDURES DESCRIBED IN THE ARTICLE WERE PERFORMED USING AN UNSPECIFIED DA VINCI SI OR SP SURGICAL SYSTEM DEVICE. THEREFORE, A GENERIC MATERIAL NUMBER HAS BEEN USED AS THE PRIMARY PRODUCT. A SYSTEM LOGS REVIEW CANNOT BE PERFORMED AT THIS TIME DUE TO INSUFFICIENT EVENT DATE INFORMATION. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE PERFORMED BECAUSE THERE IS INSUFFICIENT INFORMATION REGARDING THE DEVICE/SYSTEM AND THE EVENT DATE. THE PATIENT DEMOGRAPHICS PROVIDED REPRESENT THE DEMOGRAPHICS OF THE MAJORITY POPULATION DESCRIBED IN THE ARTICLE. CITATION (APA): DE GROOT, E. C. M., NYIRJESY, S. C., FADEN, D. L., LIN, D. T., DESCHLER, D. G., FENG, A. L., & RICHMON, J. D. (2025). SALVAGE TRANSORAL ROBOTIC SURGERY WITH SUBMENTAL FLAP RECONSTRUCTION: FUNCTIONAL AND ONCOLOGIC OUTCOMES. ANNALS OF OTOLOGY RHINOLOGY & LARYNGOLOGY, 134(11), 797¿805. HTTPS://DOI.ORG/10.1177/00034894251347103." }, { "mdr_text_key": "406281402", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF AN ARTICLE THAT EVALUATED THE PERIOPERATIVE, ONCOLOGIC, AND FUNCTIONAL OUTCOMES OF PATIENTS WITH RECURRENT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA TREATED WITH TRANSORAL ROBOTIC SURGERY (TORS) AND SUBMENTAL FLAP RECONSTRUCTION WAS PERFORMED. THE STUDY RETROSPECTIVE COHORT DESIGN ANALYZED 8 PATIENTS UNDERGOING SALVAGE TRANSORAL ROBOTIC SURGERY (TORS) WITH SUBMENTAL ISLAND FLAP RECONSTRUCTION BETWEEN DECEMBER 2019 AND FEBRUARY 2024. TWO PATIENTS WERE READMITTED TO THE HOSPITAL POSTOPERATIVELY, ONE WITH FAILURE TO THRIVE AND DEHYDRATION 6 DAYS AFTER DISCHARGE, AND THE OTHER DUE TO ALTERED MENTAL STATUS 8 DAYS AFTER DISCHARGE. ONE PATIENT HAD A NECK HEMATOMA DURING THEIR HOSPITAL ADMISSION ON POSTOPERATIVE DAY 1 THAT NECESSITATED INCISION AND DRAINAGE. PER THE AUTHOR, NO COMPLICATIONS WERE RELATED TO THE ISI DEVICE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }