{ "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": "2955842-2025-47551", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251204", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250415", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20251204", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2676926", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251204", "brand_name": "DA VINCI SP SURGICAL SYSTEM", "generic_name": "DA VINCI SP SURGICAL SYSTEM", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251215", "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": "20251204", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "53 YR", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "Kidney injury", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "Kidney injury" ] } ], "distributor_city": "", "date_report": "20251204", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23722077", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251110", "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": "386818254", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO ASSESS THE SAFETY, FEASIBILITY, AND ONCOLOGIC OUTCOMES OF COMBINING TRANSANAL TOTAL MESORECTAL EXCISION (TATME) WITH A SINGLE-PORT ROBOTIC ABDOMINAL APPROACH (RSPA) FOR LOW RECTAL CANCER. THE STUDY WAS A RETROSPECTIVE REVIEW AND ANALYZED 10 PATIENTS UNDERGOING COMBINED TATME WITH RSPA APPROACH BETWEEN (B)(6) 2022 AND (B)(6) 2024. ONE PATIENT EXPERIENCED AN ILEUS WHICH WAS MANAGED CONSERVATIVELY, AND AN ACUTE KIDNEY INJURY, WHICH WAS MANAGED WITH HYDRATION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SINGLE-PORT ROBOTIC SYSTEM. ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR STATES \"NONE OF THE COMPLICATIONS [ARE] RELATED TO THE SP ROBOT, THESE WERE ALL COMPLICATIONS THAT CAN HAPPEN AFTER ANY SUCH ABDOMINAL SURGERY.\"" }, { "mdr_text_key": "386818255", "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. NO IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE INCLUDED IN THE ARTICLE. A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALS FIVE RELATED COMPLAINTS REPORTED IN THIS CLINICAL ARTICLE. PLEASE SEE SECTION H10 FOR THE RELATED MANUFACTURER REPORT NUMBERS FOR THE OTHER SERIOUS EVENTS REPORTED IN THE SAME ARTICLE. ADDITIONAL REPORTS NOT CAPTURED IN H10 ARE 2955842-2025-47552 AND 2955842-2025-47553. CITATION: KESHK, N.O.; ET AL COMBINED TATME WITH SP ROBOT FOR LOW ANTERIOR RESECTION IN RECTAL CANCER: RSPA TATME. CANCERS 2025, 17, 1328. HTTPS://DOI.ORG/10.3390/CANCERS17081328. SECTION A2: PATIENT INFORMATION AGE: REFLECTS THE STUDY MEAN AGE OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO THE FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE WAS 11-NOV-2025. SECTION D: THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON AN UNSPECIFIED DAVINCI SP DEVICE. A GENERIC MATERIAL NUMBER IS USED AS THE PRIMARY PRODUCT. ." } ], "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": "" } ] }