{ "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": "2955842-2024-23024", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241210", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240620", "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": "KS", "manufacturer_contact_area_code": "408", "date_added": "20241211", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2597486", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241210", "brand_name": "DA VINCI SP", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601", "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": "20250822", "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": "20241210", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "65 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hernia", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Hernia", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20241115", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20899224", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241115", "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": "358829770", "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. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATION: OH, S, YI, J, SONG, AY, ET AL. INTRAOPERATIVE COMPLICATIONS AND PERIOPERATIVE AND SURGICAL OUTCOMES OF SINGLE-PORT ROBOTICS-ASSISTED SACROCOLPOPEXY. INT UROGYNECOL J 35, 1521¿1526 (2024). HTTPS://DOI.ORG/10.1007/S00192-024-05796-2 SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE SPECIFIC PATIENTS. THE MEAN AGE OF THE PATIENTS WAS 65 YEARS, AND PATIENTS WERE FEMALES ACCORDING TO THE TYPE OF THE PROCEDURE. FIELD 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 MATERIAL NUMBER WAS USED." }, { "mdr_text_key": "358829771", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY THAT ASSESSED THE INTRAOPERATIVE AND SURGICAL OUTCOMES OF 200 PATIENTS BY A SINGLE SURGEON THAT UNDERWENT SINGLE PORT ROBOTIC-ASSISTED SACROCOLPOPEXY (SCP) TO TREAT PELVIC ORGAN PROLAPSE FROM APRIL 2020 TO AUGUST 2023 IN ONE INSTITUTION. ALL PROCEDURES WERE COMPLETED WITHOUT CONVERSIONS TO LAPAROSCOPY OR LAPAROTOMY. INTRAOPERATIVE COMPLICATIONS WERE NOTED AS FIVE INTRAOPERATIVE CYSTOTOMIES; TWO OF THEM OCCURRED DURING THE DISSECTION OF THE VESICOVAGINAL SPACE, AND ALL OF THEM WERE REPAIRED SUCCESSFULLY. THERE WERE 2 CASES OF BOWEL INJURIES, 4 VAGINAL WALL TEAR, AND 1 SACRAL VESSEL INJURY THAT WERE REPAIRED INTRA-OPERATIVELY. POST-OPERATIVELY, FOUR PATIENTS WERE FOUND WITH UMBILICAL WOUND HERNIAS WITH ONE ELECTING SURGICAL REPAIR. A PATIENT WAS FOUND WITH MESH EXPOSURE AND WAS MANAGED CONSERVATIVELY WITH TOPICAL ESTROGEN. THERE WAS NO DA VINCI DEVICE MALFUNCTIONS OR ISSUES MENTIONED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT 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": "" } ] }