{ "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": "2955842-2024-22434", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241202", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240520", "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": "20241202", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "132418", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241202", "brand_name": "DA VINCI", "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": "UNKNOWN", "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": "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": "20241202", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Hemorrhage/Blood Loss/Bleeding", "Hernia", "Wound Dehiscence", "Hemorrhage/Blood Loss/Bleeding", "Hernia" ] } ], "distributor_city": "", "date_report": "20241108", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20825126", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241108", "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": "358105444", "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: CHOI SH, WON S, LEE N, SHIM SH, KIM MK, KIM ML, JUNG YW, YUN BS, JUN HS, SEONG SJ. ROBOTIC SINGLE-SITE PLUS ONE-PORT MYOMECTOMY VERSUS ROBOTIC SINGLE-SITE PLUS TWO-PORT MYOMECTOMY: A PROPENSITY SCORE MATCHING ANALYSIS. YONSEI MED J. 2024 JUL;65(7):406-412. HTTPS://DOI.ORG/10.3349/YMJ.2023.0434. 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 WAS USED." }, { "mdr_text_key": "358105445", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY TO EVALUATE THE METHODOLOGIES AND SURGICAL OUTCOMES OF ROBOTIC SINGLE-SITE PLUS ONE-PORT MYOMECTOMY (RSOM) WITH ROBOTIC SINGLE-SITE PLUS ONE-PORT MYOMECTOMY (RSOM). 230 PATIENTS WHO HAD UNDERGONE RSOM AND 146 PATIENTS WHO HAD UNDERGONE RSTM BETWEEN SEPTEMBER 2020 AND SEPTEMBER 2021 AT A SINGLE INSTITUTION WERE REVIEWED, ALL WERE USING DA VINCI-X OR XI ROBOTIC SYSTEM. IN THE RSTM GROUP, THE POSTOPERATIVE COMPLICATIONS INCLUDED ONE CASE OF WOUND DEHISCENCE THAT THE LEFT SIDE TROCAR INCISION WAS REOPENED, AND RE-SUTURING WAS PERFORMED.; IN THE RSOM GROUP, THERE WAS ONE CASE OF REOPERATION REQUIRED REOPERATION ON POSTOPERATIVE DAY 1. IT WAS PROVIDED THAT AN EMERGENT LAPAROSCOPIC REOPERATION WAS PERFORMED DUE TO HEMOPERITONEUM RESULTING FROM BLEEDING AT THE UMBILICAL INCISION SITE. SUCTION AND IRRIGATION, HEMOSTASIS OF INCISION SITE, AND TRANSFUSION WERE PERFORMED, AND THE PATIENT RECOVERED WELL. ANOTHER PATIENT IN THE RSOM EXPERIENCED AN APPROXIMATELY 4-CM UMBILICAL HERNIA 4 MONTHS POST PROCEDURE, AND HERNIORRHAPHY WAS PERFORMED WITHOUT ANY COMPLICATION. NO CASE OF CONVERSION TO LAPAROTOMY OR ADDITIONAL TROCAR INSERTION WAS FOUND IN BOTH GROUPS. THERE WAS NO MENTION OF ANY DA VINCI DEVICE ISSUES 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": "" } ] }