{ "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": "2955842-2024-22420", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241204", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240621", "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", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20241204", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2108480", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241204", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": "20241204", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "59 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Obstruction/Occlusion", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20241106", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20839817", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241106", "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": "358208773", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN JANUARY 2021 AND AUGUST 2023 OF 69 PATIENTS THAT UNDERWENT DA VINCI SINGLE PORT (SP) ASSISTED ROBOTIC HYSTERECTOMY WITH CONCOMITANT SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE (POP) AT TWO TERTIARY CARE CENTERS, PERFORMED BY FIVE TRAINED SURGEONS. THE STUDY WAS CONDUCTED TO EVALUATE THE SHORT-TERM OUTCOMES OF THE PATIENTS UNDERWENT SP ASSISTED HYSTERECTOMY WITH CONCOMITANT SACROCOLPOPEXY POP. THE PROCEDURES WERE ALL COMPLETED EXCEPT FOR ONE CASE OF CONVERSION TO OPEN SURGERY. THE MEDIAN OPERATIVE TIME WAS 209 MINUTES, MEDIAN ESTIMATED BLOOD LOSS WAS 100ML. ONE PATIENT EXPERIENCED A MAJOR VASCULAR INJURY DURING PRESACRAL DISSECTION AND REQUIRED CONVERSION TO LAPAROTOMY. FIVE POST-OPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE WHICH INCLUDED TWO CASES OF SMALL BOWEL OBSTRUCTION, ONE OF THEM WAS RESOLVED BY CONSERVATIVE MANAGEMENT, AND ONE REQUIRED SURGICAL MANAGEMENT. A PATIENT EXPERIENCED PELVIC HEMATOMA REQUIRING A BLOOD TRANSFUSION, AND 1 CASE OF VENTRAL HERNIA THAT REQUIRED SUBSEQUENT REPAIR. ONE PATIENT HAD VAGINAL MESH EXPOSURE, AND THE PATIENT ELECTED TO UNDERGO SURGICAL EXCISION. THERE WAS NO MENTION OF ANY DA VINCI DEVICE ISSUES IN THE ARTICLE. THE DESIGNATED AUTHOR WAS CONTACTED AND HAVE CONFIRMED THAT THERE WERE NO DEVICE MALFUNCTIONS OCCURRED DURING THE PROCEDURES." }, { "mdr_text_key": "358208774", "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: ASHMORE, S., KENTON, K., COLLINS, S. ET AL. SHORT-TERM OUTCOMES OF SINGLE PORT ROBOTIC HYSTERECTOMY WITH CONCOMITANT SACROCOLPOPEXY. J ROBOTIC SURG 18, 260 (2024). HTTPS://DOI.ORG/10.1007/S11701-024-02029-Y. A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. STUDY DEMOGRAPHICS IN THE ROBOTIC GROUP INCLUDED PATIENTS WITH A MEDIAN AGE OF 59 YEARS ; THE GENDER IS FEMALE ACCORDING TO THE TYPE OF THE PROCEDURES. 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. E: THE PROCEDURES WERE MENTIONED PERFORMED IN TWO SITES ACCORDING TO THE ARTICLE, THE UNIVERSITY OF CHICAGO AND NORTHWESTERN MEDICINE. THIS REPORT HAS BEEN REPORTED UNDER THE FACILITY THAT THE AUTHOR IS FROM." } ], "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": "" } ] }