{ "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": "2955842-2026-04833", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260218", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250531", "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", "Study", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20260218", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "436742", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260218", "brand_name": "DA VINCI SURGICAL SYSTEMS", "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": "UNKNOWN", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260218", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260218", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24379532", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260121", "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": "393304658", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE \"SURGICAL OUTCOMES OF ROBOTIC HYSTERECTOMY FOR LARGE UTERUS WEIGHING MORE THAN 1000 G: A RETROSPECTIVE STUDY FROM A HIGH-VOLUME CENTER\" WAS PERFORMED. THIS RETROSPECTIVE STUDY DATA FROM THE HOSPITAL WAS REVIEWED BETWEEN JANUARY 2014 TO DECEMBER 2023 AND AIMED TO INVESTIGATE THE IMPACT OF VARIOUS RISK FACTORS ON SURGICAL OUTCOMES AND TO IDENTIFY THE MOST EFFECTIVE SURGICAL APPROACH FOR PERFORMING RADICAL HYSTERECTOMIES ON UTERI GREATER THAN 1000 G IN BENIGN CONDITIONS. A TOTAL OF 86 PATIENTS WERE INCLUDED IN THE ANALYSIS, AND THE AVERAGE AGE OF THE STUDY POPULATION WAS 47.1 +/- 4.5 YEARS, WITH A MEAN BODY MASS INDEX OF 25.1 +/- 4.0 KG/M2. THE ARTICLE DESCRIBES SOME SPECIFIC INTRA-OPERATIVE COMPLICATIONS WITH MINIMAL DETAILS. A SMALL PERCENTAGE OF PATIENTS (4.7%) REQUIRED CONVERSION TO OPEN SURGERY. A TOTAL OF 4 INCIDENTS OF ORGAN INJURIES WERE RECORDED; ONE PATIENT EXPERIENCED A BLADDER INJURY, AND THREE PATIENTS EXPERIENCED VAGINAL LACERATIONS, ALL OF WHICH REQUIRED INTRAOPERATIVE REPAIR WITHOUT SUBSEQUENT COMPLICATIONS. ADDITIONALLY, SIX CASES NECESSITATED INTRAOPERATIVE BLOOD TRANSFUSIONS. POST-OPERATIVELY, ONE PATIENT SUFFERED A CUFF INFECTION AND URINARY TRACT INFECTION REQUIRING ANTIBIOTIC THERAPY, AND ANOTHER PATIENT EXPERIENCED CUFF DEHISCENCE AND BLEEDING LEADING TO READMISSION AND RESOLUTION AFTER SECONDARY SUTURE, AND ONE PATIENT EXPERIENCED URINARY RETENTION REQUIRING CATHETERIZATION FOR 2 WEEKS. 11 CASES REQUIRED POST-OPERATIVE BLOOD TRANSFUSIONS. THE AUTHORS CONCLUDED THAT ROBOTIC HYSTERECTOMY (RH) WAS FEASIBLE AND SAFE EVEN IN CASES OF LARGE UTERI WEIGHING MORE THAN 1000 G. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT." }, { "mdr_text_key": "393304659", "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. CITATION: ZHAO, L., XIE, X., ZHANG, N., XU, J., YANG, W., FAN, W., MENG, Y., LI, L. AND GU, C. (2025C). SURGICAL OUTCOMES OF ROBOTIC HYSTERECTOMY FOR LARGE UTERUS WEIGHING MORE THAN 1000 G: A RETROSPECTIVE STUDY FROM A HIGH-VOLUME CENTER. JOURNAL OF ROBOTIC SURGERY, 19(1), 253. HTTPS://DOI.ORG/10.1007/S11701-025-02422-1 DEMOGRAPHIC INFORMATION: AVERAGE AGE 47.1+/- 4.5 YEARS; MEAN BODY MASS INDEX (BMI) OF 25.1 +/- 4.0 KG/M2." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }