{ "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": "2955842-2023-15153", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230530", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20230501", "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": "20230530", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1728049", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230530", "brand_name": "DA VINCI", "generic_name": "PATIENT SIDE CART", "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": "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": "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": "20250724", "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": "20230530", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "47 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Urinary Retention", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Urinary Retention", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230501", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17023243", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230501", "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": "316198161", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION GATHERED, THE CAUSES OF THE COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ARTICLE CITATION: JEONG, S.Y.; KIM, K.; RYU, J.W.; CHA, J.; PARK, S.T.; PARK, S.H. COMPARISON OF SURGICAL OUTCOMES OF ROBOTIC VERSUS CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY OF LARGE UTERUS WITH GYNECOLOGIC BENIGN DISEASE. J. PERS. MED. 2022, 12, 2042. AVAILABLE FROM: HTTPS:// DOI.ORG/10.3390/JPM12122042." }, { "mdr_text_key": "316198162", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI-ASSISTED ROBOTIC PROCEDURES TITLED, ¿COMPARISON OF SURGICAL OUTCOMES OF ROBOTIC VERSUS CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY OF LARGE UTERUS WITH GYNECOLOGIC BENIGN DISEASE¿ (JEONG, S.Y., ET AL., 2023) THE FOLLOWING EVENTS WERE REPORTED. AS PART OF A RETROSPECTIVE COHORT STUDY AT A SINGLE CENTER BETWEEN JANUARY 2014 AND JULY 2022, A TOTAL OF 397 PATIENTS (197 PATIENTS UNDERWENT ROBOTIC HYSTERECTOMY, 200 PATIENTS UNDERWENT CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY) WHO UNDERWENT MINIMALLY INVASIVE HYSTERECTOMY FOR BENIGN DISEASES WITH UTERINE SIZE EXCEEDING 250G WERE ENROLLED. INTRA-OPERATIVELY, SIX PATIENTS RECEIVED BLOOD TRANSFUSIONS AND 4 PATIENTS HAD URETERAL INJURY. POST-OPERATIVELY, 101 PATIENTS EXPERIENCED URINARY RETENTION WITH CATHETERIZATION WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 1. TRANSFUSION AND ANTIBIOTIC USE WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 2 AND WERE SEEN IN 16 PATIENTS. TWO PATIENTS HAD CLAVIEN-DINDO GRADE 3 POST-OPERATIVE COMPLICATIONS, WITH NO FURTHER DETAILS. THERE IS NO INFORMATION REGARDING THE MEDICAL INTERVENTIONS THAT WERE PERFORMED. INTUITIVE SURGICAL, INC, (ISI) MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." } ], "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": "" } ] }