{ "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": "2955842-2025-47552", "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": "1100824", "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": [ "Bacterial Infection", "Obstruction/Occlusion", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "Bacterial Infection", "Obstruction/Occlusion", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available" ] } ], "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": "23721052", "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": "386824568", "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 2955842-2025-47551 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." }, { "mdr_text_key": "386824569", "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 MAY 2022 AND AUGUST 2024. ONE PATIENT EXPERIENCED AN ABSCESS TREATED WITH ANTIBIOTICS, AND A SMALL BOWEL OBSTRUCTION WHICH WAS MANAGED CONSERVATIVELY. 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.\"" } ], "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": "" } ] }