{ "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": "2955842-2024-21067", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241023", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240504", "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": "GM", "manufacturer_contact_area_code": "408", "date_added": "20241023", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "28000", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241023", "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": "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": "20241023", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "68 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Inflammation", "Bowel Perforation", "Liver Failure", "Inflammation", "Bowel Perforation", "Liver Failure" ] } ], "distributor_city": "", "date_report": "20241001", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20515868", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241001", "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": "354879568", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A CLINICAL ARTICLE THAT ASSESSED THE EFFECTIVENESS AND SAFETY OF ROBOTIC SECTIONECTOMY (RS) VERSUS ROBOTIC (EXTENDED) HEMIHEPATECTOMY (RH) FOR THE TREATMENT OF LIVER TUMORS WAS REVIEWED. THE STUDY INCLUDED 30 PATIENTS BETWEEN MARCH 2021 AND JULY 2023 THAT UNDERWENT HEPATECTOMIES IN ONE SINGLE INSTITUTION. A TOTAL OF 16 PATIENTS UNDERWENT RS, AND 14 PATIENTS UNDERWENT RH. AMONG THE 30 PATIENTS, ONE PATIENT IN EACH STUDY GROUP WAS CONVERTED TO OPEN HEPATECTOMY DUE TO ONCOLOGICAL SAFETY (ONE PATIENT WITH A BISMUTH TYPE IIIB PERIHILAR CHOLANGIOCARCINOMA WHO WAS ADMITTED FOR LEFT HEPATECTOMY BUT UNDERWENT EXTENDED LEFT HEPATECTOMY) AND DUE TO MULTIPLE ADHESIONS (ONE PATIENT WITH RECURRENT COLORECTAL LIVER METASTASES AFTER NON-ANATOMIC SEGMENT II RESECTION WHO WERE ADMITTED FOR LEFT LATERAL SECTIONECTOMY). THERE WAS NO INTRAOPERATIVE COMPLICATIONS MENTIONED IN THE ARTICLE. POST-OPERATIVELY, A TRANSIENT POSTHEPATECTOMY LIVER FAILURE, WHICH WAS ASSESSED AS INTERNATIONAL STUDY GROUP OF LIVER SURGERY(ISGLS) GRADE A, WAS REPORTED IN ONE PATIENT AFTER AN EXTENDED RIGHT HEPATECTOMY. POSTHEPATECTOMY BILE LEAKS (ISGLS GRADE B) WERE OBSERVED IN ONE PATIENT IN THE RH GROUP AND THREE PATIENTS IN THE RS GROUP, WHICH WERE MANAGED BY INTERVENTIONAL PERCUTANEOUS DRAINS. TWO PATIENTS IN THE RS GROUP WERE REVISED LAPAROSCOPICALLY, OF WHOM ONE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY DUE TO POSTOPERATIVE CHOLECYSTITIS AFTER ROBOTIC LEFT LATERAL SECTIONECTOMY, AND ONE PATIENT UNDERWENT A LAPAROSCOPIC EXPLORATION TO RULE OUT BOWEL PERFORATION AFTER ROBOTIC POSTERIOR SECTIONECTOMY WITH EXTENSIVE ADHESIOLYSIS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED." }, { "mdr_text_key": "354879569", "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: BIRGIN, E., HEIBEL, M., TÉOULE, P. ET AL. ROBOTIC SECTIONECTOMY VERSUS ROBOTIC HEMIHEPATECTOMY FOR ANATOMIC LIVER RESECTION: A COMPARATIVE ANALYSIS OF PERIOPERATIVE OUTCOMES. J ROBOTIC SURG 18, 197 (2024). HTTPS://DOI.ORG/10.1007/S11701-023-01751-3. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS THAT HAD COMPLICATIONS. MEDIAN AGE OF THE PATIENTS WAS 68 YEARS, THE MAJORITY (63%) 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." } ], "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": "" } ] }