{ "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": "2955842-2024-18175", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240815", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240130", "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": "", "manufacturer_contact_area_code": "408", "date_added": "20240815", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1619608", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240815", "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": "DA", "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": "09/09/2024", "mfr_report_type": "Follow-Up", "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": "20240815", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "36 YR", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240717", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19990412", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240717", "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": "349349449", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT REFLECTS ADVERSE EVENT-ONLY DATA FROM A LITERATURE ARTICLE.  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. THE DESIGNATED AUTHOR WAS CONTACTED FOR ADDITIONAL INFORMATION UNSUCCESSFULLY.   CITATIONS: OPTIMIZING ROBOTIC THYROID SURGERY: LESSONS LEARNED FROM AN RETROSPECTIVE ANALYSIS OF 104 CASES. DOI 10.3389/FENDO.2024.1337322." }, { "mdr_text_key": "349349450", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE STUDY ASSESSED THE IMPACT OF THE DA VINCI SURGICAL SYSTEM ON THYROID SURGERY BY ANALYZING 104 ROBOTIC THYROIDECTOMY CASES PERFORMED FROM MARCH 2018 TO JANUARY 2022. THE SURGERIES UTILIZED BOTH THE SI AND XI MODELS OF THE DA VINCI SURGICAL SYSTEM IN SEQUENCE. THE STUDY AIMED TO DETERMINE IF, AFTER AN INITIAL LEARNING CURVE, THE SYSTEM WOULD REDUCE OPERATIVE TIMES WHILE MAINTAINING LOW COMPLICATION RATES, THEREBY ENHANCING PATIENT CARE. RESULTS SHOWED A DECREASE IN TRANSIENT POSTOPERATIVE COMPLICATIONS, WITH THE INCIDENCE OF VOCAL CORD PALSY FALLING FROM 5.4% IN EARLY CASES TO 1.5% IN LATER CASES. THERE WERE NO REPORTED PERMANENT INJURIES TO THE RECURRENT LARYNGEAL NERVE OR CASES OF PERMANENT HYPOPARATHYROIDISM. EARLY-PHASE ISSUES INCLUDED RARE INSTANCES OF POSTOPERATIVE HEMORRHAGE AND TRACHEAL INJURY. NO ISI- PRODUCTS RELATED MALFUNCTIONS WERE MENTIONED IN THE ARTICLES. THE STUDY CONCLUDED THAT AS SURGEONS GAINED EXPERIENCE, ROBOTIC ASSISTANCE IMPROVED SURGICAL PRECISION AND LED TO CONSISTENT OUTCOMES. HOWEVER, IT NOTED LIMITATIONS SUCH AS THE SMALL SAMPLE SIZE, SHORT FOLLOW-UP DURATION, AND LACK OF COMPARISON WITH OTHER THYROIDECTOMY APPROACHES. ALTHOUGH SURGERY DURATION REDUCED, THIS WAS NOT STATISTICALLY SIGNIFICANT FOR COMPLICATION RATES, SUGGESTING THAT THE IMPROVEMENTS MIGHT BE MORE ATTRIBUTABLE TO SURGEON FAMILIARITY WITH THE ROBOTIC EQUIPMENT RATHER THAN THE SYSTEM ITSELF." }, { "mdr_text_key": "353037847", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FOLLOW UP RESPONSE WAS RECEIVED AND THE AUTHOR REPORTED THAT HOARSENESS AND POSTOPERATIVE BLEEDING OCCUR EQUALLY IN BOTH CONVENTIONAL AND ROBOTIC TECHNIQUES. A RARE TRACHEAL INJURY DURING A SPECIFIC ROBOTIC PROCEDURE WAS DEEMED AN ANOMALY, THAT OCCURRED WHILE TREATING A RARE CONDITION AND WAS NOT INHERENTLY LINKED TO THE ROBOTIC EQUIPMENT. TRACHEAL INJURIES OF THIS NATURE ARE EXCEEDINGLY RARE, AND THE DISCUSSION REFERENCES A RELEVANT PUBLICATION FOR FURTHER CONTEXT. THE REPORT ALSO CONFIRMED THAT NO REOPERATIONS OR FATALITIES WERE ASSOCIATED WITH THE DA VINCI ROBOTIC SYSTEM." } ], "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": "09/27/2024" } ] }