{ "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": "2955842-2024-23394", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241218", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240410", "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": "DA", "manufacturer_contact_area_code": "408", "date_added": "20241218", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1485624", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241218", "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": "UNKNOWN", "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": "20250827", "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": "20241218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "63 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiogenic Shock", "Thromboembolism", "Cardiogenic Shock", "Thromboembolism" ] } ], "distributor_city": "", "date_report": "20241119", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20960609", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241119", "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": "359440955", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE THAT DESCRIBED A COHORT STUDY OF 2225 PATIENTS THAT UNDERWENT ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY FROM JANUARY 2015 TO DECEMBER 2022. THE AIM OF THE STUDY WAS TO PROVIDE A COMPREHENSIVE DESCRIPTION OF PERIOPERATIVE MORBIDITY ASSOCIATED WITH ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY TO ENHANCE PREOPERATIVE COUNSELING AND SUPPORT SHARED DECISION-MAKING. A GYNECOLOGICAL ONCOLOGIST PERFORMED THE SURGERY IN 98% OF THE CASES, AND 64% OF THESE SURGEONS WERE ALREADY EXPERIENCED IN RAS (>50 ROBOTIC PROCEDURES). THE DA VINCI SI SYSTEM WAS USED IN 524 CASES AND THE DA VINCI XI SYSTEM IN 1701 CASES. AMONG THE 2225 PATIENTS, THE ARTICLE NOTED THAT ONE PATIENT DIED DUE TO CARDIOGENIC SHOCK 2 WEEKS AFTER UNCOMPLICATED RAS, THE CAUSE OF DEATH WAS FOUND TO BE MAJOR THROMBOEMBOLIC EVENT (TEE). THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENTS. THE STUDY CONCLUDED THAT RAS IN A HIGH-VOLUME GYNECOLOGICAL ONCOLOGY SETTING RESULTED IN LOW RATES OF MAJOR PERIOPERATIVE MORBIDITY AND CONVERSION TO LAPAROTOMY. THE FINDINGS SUPPORT THE USE OF RAS FOR SUITABLE PATIENTS AND HIGHLIGHT ITS SAFETY PROFILE WHEN PERFORMED BY EXPERIENCED SURGEONS. THE DESIGNATED AUTHOR WAS CONTACTED AND CONFIRMED THAT THE PATIENT'S DEATH WAS NOT CAUSED OR CONTRIBUTED BY ANY OF THE DA VINCI DEVICES." }, { "mdr_text_key": "359440956", "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. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER CONCLUDED THAT BASED ON THE INFORMATION IN THE SUMMARY OF EVENTS, NO INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT. THIS REPORT DESCRIBES A DEATH FROM A THROMBOEMBOLIC EVENT 2 WEEKS AFTER ROBOTIC SURGERY FOR GYNECOLOGICAL ONCOLOGY. THROMBOEMBOLIC EVENTS OCCUR IN AS MANY AS 1% OF GYNECOLOGICAL ONCOLOGY PATIENTS AND THE RATE QUOTED IN THIS PAPER IS WELL BELOW THIS HISTORICAL LITERATURE RATE. NO ALLEGATION IS MADE AGAINST ANY ROBOTIC INSTRUMENTS OR EQUIPMENT. GIVEN THE AVAILABLE INFORMATION, THE EVENT IS NOT RELATED TO ANY INTUITIVE SURGICAL PRODUCTS AND IS POSSIBLY RELATED TO THE PROCEDURE. VENOUS THROMBOEMBOLIC EVENTS IN MINIMALLY INVASIVE GYNECOLOGIC SURGERY. PEDRO T RAMIREZ, ALPA M NICK, MICHAEL FRUMOVITZ, KATHLEEN M SCHMELER. J MINIM INVASIVE GYNECOL. AUTHOR MANUSCRIPT; AVAILABLE IN PMC: 2015 MAR 16. PUBLISHED IN FINAL EDITED FORM AS: J MINIM INVASIVE GYNECOL. 2013 JUL 11;20(6):766¿769. DOI: 10.1016/J.JMIG.2013.06.001. CITATION: MARKAUSKAS A, BLAAKAER J, TRAEN KJ, NEUMANN GA, CHUNSEN W, PETERSEN LK. MORBIDITY FOLLOWING ROBOT-ASSISTED SURGERY IN A GYNECOLOGICAL ONCOLOGY SETTING: A COHORT STUDY. ACTA OBSTET GYNECOL SCAND. 2024 AUG;103(8):1672-1679. DOI: 10.1111/AOGS.14852. EPUB 2024 JUN 14. PMID: 38874351; PMCID: PMC11266637. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THIS PATIENT. THE MEAN OF THE PATIENTS WAS 63 YEARS, AND PATIENTS WERE ALL FEMALES ACCORDING TO THE TYPE OF THE PROCEDURE 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 MATERIAL NUMBER WAS USED." } ], "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": "" } ] }