{ "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": "2955842-2025-44995", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251113", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20251021", "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": "CH", "manufacturer_contact_area_code": "408", "date_added": "20251113", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "587925", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251113", "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": "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": "20251215", "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": "20251113", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Other" ], "patient_age": "66 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dysphagia/ Odynophagia", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Dysphagia/ Odynophagia", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20251113", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23542437", "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": "385001593", "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 ANY DA VINCI PRODUCT ISSUES, AND NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT EVENT INFORMATION. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE WAS 21-OCTOBER-2025. DEMOGRAPHICS OF THE PATIENT POPULATION: 24 MALES (88.9%), 3 FEMALES (11.1%). AGE RANGE (YEARS) IS 40¿75 YEARS. CITATION: XU, K., TAO, L., WANG, Y., LIANG, F., XU, C., DENG, L., ZOU, X., LU, X., HUANG, X., & HAN, P. (2025). MULTICENTER RETROSPECTIVE STUDY OF TRANSORAL ROBOTIC SURGERY FOR SUPRAGLOTTIC LARYNGEAL CANCER. CHINESE JOURNAL OF OTOLARYNGOLOGY, HEAD AND NECK SURGERY, 60(3), 266-271. HTTPS://DOI.ORG/10.3760/CMA.J.CN115330-20240807-00466." }, { "mdr_text_key": "385001594", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO INVESTIGATE THE SAFETY, EFFICACY, AND SHORT-TERM OUTCOMES OF TRANSORAL ROBOTIC SURGERY (TORS) FOR SUPRAGLOTTIC LARYNGEAL CANCER. THE STUDY, A MULTICENTER RETROSPECTIVE ANALYSIS, ANALYZED 27 PATIENTS UNDERGOING TRANSORAL ROBOTIC SURGERY (TORS) BETWEEN JANUARY 2018 AND APRIL 2024. A TOTAL OF 27 PATIENTS WITH SUPRAGLOTTIC LARYNGEAL CANCER WERE ENROLLED IN 4 CENTERS, INCLUDING 24 MALES AND 3 FEMALES. A TOTAL OF SEVERAL PATIENTS EXPERIENCED PERIOPERATIVE COMPLICATIONS, INCLUDING PALATAL ARCH MUCOSAL INJURY IN 23 CASES (85.19%), DYSPHAGIA IN 4 CASES (14.81%), INCISOR INJURY IN 1 CASE (3.70%), AND LARYNGEAL BLEEDING IN 1 CASE (3.70%) OCCURRING ONE WEEK AFTER SURGERY, WHICH CEASED AFTER APPROXIMATELY 30 ML BLOOD LOSS AND WAS ATTRIBUTED TO DETACHMENT OF THE HIBICOBINA ALBA IN THE OPERATIVE CAVITY. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SURGICAL SYSTEM. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED." } ], "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": "" } ] }