{ "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": "2955842-2024-23176", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241213", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240605", "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": "UK", "manufacturer_contact_area_code": "408", "date_added": "20241213", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1937228", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241213", "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": "", "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": "20241213", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available" ] } ], "distributor_city": "", "date_report": "20241120", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20929776", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241120", "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": "359208754", "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 THE DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. CITATION: SICKINGHE A, NOBBENHUIS M, NELISSEN E, HEATH O, AND IND T (2024) PROFICIENCY-BASED PROGRESSION TRAINING IN ROBOT-ASSISTED LAPAROSCOPY FOR ENDOMETRIAL CANCER: PERI-OPERATIVE AND SURVIVAL OUTCOMES FROM AN OBSERVATIONAL COHORT STUDY. FRONT. MED. 11:1370836. HTTPS://DOI: 10.3389/FMED.2024.1370836. IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, THE PRODUCT IS REPORTED AS NOT APPLICABLE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. NO SPECIFIC DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. STUDY DEMOGRAPHICS INCLUDED ONLY WOMEN. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. SECTION D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. SECTIONS G5 AND G7 ARE NOT APPLICABLE. FIELD H4 IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "359208755", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED AN OBSERVATIONAL COHORT STUDY WHICH WAS TO ASSESS THE IMPACT OF A PROFICIENCY-BASED PROGRESSION TRAINING CURRICULUM ON PERI-OPERATIVE AND SURVIVAL OUTCOMES FOR ENDOMETRIAL CANCER. THE STUDY OCCURRED FROM 2015 TO 2022 AND INCLUDED 594 WOMEN DIAGNOSED WITH PRIMARY ENDOMETRIAL CANCER TREATED WITH ROBOT-ASSISTED LAPAROSCOPIC SURGERY, WHICH TYPICALLY INVOLVED HYSTERECTOMY AND SALPINGO-OOPHORECTOMY ALONG WITH SOME FORM OF PELVIC LYMPH NODE DISSECTION. THE ARTICLE STATED MANY INTRAOPERATIVE COMPLICATIONS, WHICH WERE SLIGHTLY LOWER IN THE NON-TRAINING GROUP AT 4.8% COMPARED TO 7.7% IN THE TRAINING GROUP. GRADES 3A AND 3B COMPLICATIONS OCCURRED AT SIMILAR LOW FREQUENCIES ACROSS BOTH GROUPS, WHILE GRADE 4A COMPLICATIONS WERE EQUALLY RARE AT 0.7% IN BOTH GROUPS. READMISSION RATES WITHIN 30 DAYS WERE LOWER IN THE TRAINING GROUP (3.8%) COMPARED TO THE NON-TRAINING GROUP (6.0%). RETURNS TO THE THEATER WERE INFREQUENT IN BOTH GROUPS, OCCURRING AT 1.0% IN THE TRAINING GROUP AND 1.7% IN THE NON-TRAINING GROUP. LYMPHOEDEMA RATES WERE ALSO COMPARABLE, NOTED AT 8.4% IN THE TRAINING GROUP VERSUS 11.3% IN THE NON-TRAINING GROUP. THERE WERE NO DA VINCI DEVICE ISSUES MENTIONED IN THE ARTICLE. REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE; NO RESPONSE HAS BEEN RECEIVED." } ], "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": "" } ] }