{ "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": "2955842-2023-14504", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230523", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230427", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20230523", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1463740", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230523", "brand_name": "DA VINCI SP", "generic_name": "SURGEON SIDE CONSOLE", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380940-33", "catalog_number": "380940", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": "", "date_changed": "20250725", "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": "20230523", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230427", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16987120", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230427", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "315835946", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 27-APR-2023, JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿COMPARATIVE STUDY OF SUPRACERVICAL HYSTERECTOMY BETWEEN DA VINCI SP ® SURGICAL SYSTEM AND CONVENTIONAL SINGLE SITE LAPAROSCOPY FOR UTERINE FIBROID: SINGLE CENTER EXPERIENCES¿ (LEE, J., HONG, D.G., 2023). WITHIN THE JOURNAL ARTICLE, IT WAS MENTIONED 31 PATIENTS UNDERWENT SUPRACERVICAL HYPSTERECTOMY WITH THE DA VINCI SP SURGICAL SYSTEM FOR UTERINE FIBROID BETWEEN JUNE 2018 AND APRIL 2021. OF THE 31 PATIENTS, THERE WERE 2 (6.4%) OPERATIVE COMPLICATIONS. ONE WAS VAGINAL WALL PERFORATION DURING DISSECTION, THE SURGEON SUTURED IMMEDIATELY AND THERE WAS NO REPORTED HEMORRHAGE OR INFECTION. THE OTHER COMPLICATION WAS A MASSIVE HEMORRHAGE FROM THE PRESERVED UTERINE CERVIX, WHICH WAS TREATED WITH EMERGENT TRANSVAGINAL CERVICECTOMY. A LONGER OPERATION TIME AND HIGHER LEVELS OF C-REACTIVE PROTEIN (CRP) WERE FOUND IN THE ROBOTIC SURGICAL GROUP, NO SIGNIFICANT DIFFERENCES WERE FOUND IN OTHER SURGICAL OUTCOMES SUCH AS COMPLICATION RATES AND HOSPITAL STAYS. THE ARTICLE AUTHOR THOUGHT THE REASONS FOR THE SIGNIFICANTLY HIGHER CRP LEVELS WERE DUE TO UMBILICAL INCISION WAS LARGER IN ROBOTIC SURGERY WHICH WAS 0.5-1CM LONGER THAN SINGLE SITE LAPAROSCOPY. THE AUTHOR ALSO THOUGHT THAT THE LONGER OPERATIVE TIME AND LIMITED SPACE TO WORK, WHICH CAN AFFECT THE SUCTION USAGE COULD BE ONE OF THE REASONS TOO. INTUITIVE SURGICAL, INC, (ISI) MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." }, { "mdr_text_key": "315835947", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE MENTIONED COMPLICATIONS CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF ROBOTIC SURGERY ARTICLE, AND IT WAS MENTIONED 31 PATIENTS WHO UNDERWENT SUPRACERVICAL HYPSTERECTOMY WITH THE DA VINCI SP SURGICAL SYSTEM FOR UTERINE FIBROID, THERE WERE 2 (6.4%) OPERATIVE COMPLICATIONS. ONE WAS VAGINAL WALL PERFORATION DURING DISSECTION, THE SURGEON SUTURED IMMEDIATELY AND THERE WAS NO REPORTED HEMORRHAGE OR INFECTION. THE OTHER COMPLICATION WAS A MASSIVE HEMORRHAGE FROM THE PRESERVED UTERINE CERVIX, WHICH WAS TREATED WITH EMERGENT TRANSVAGINAL CERVICECTOMY. SECTION A PATIENT DEMOGRAPHIC IS DOCUMENTED WAS 45 YEARS (MEAN AGE OF THE ROBOTIC GROUP)" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }