{ "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": "2955842-2024-20050", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241003", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20230924", "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": "JA", "manufacturer_contact_area_code": "408", "date_added": "20241003", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2015535", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241003", "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": "N/A", "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": "20250821", "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": "20241003", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Abscess", "Unspecified Infection", "Failure to Anastomose", "Abscess", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20240910", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20358554", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240910", "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": "353231496", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING REVIEW OF A LITERATURE ARTICLE WHICH COMPARED INTRA-ABDOMINAL INFECTIOUS COMPLICATIONS OF ROBOTIC ASSISTED GASTRECTOMY SURGICAL PROCEDURES WITH LAPAROSCOPIC GASTRECTOMY SURGICAL PROCEDURES, THE FOLLOWING WAS IDENTIFIED: THIS RETROSPECTIVE, SINGLE-INSTITUTION STUDY AIMED TO ASSESS WHETHER ROBOTIC SURGERY (RG) OFFERS CLINICAL BENEFITS OVER LAPAROSCOPIC SURGERY (LG) FOR OBESE PATIENTS, LEVERAGING THE ROBOT¿S MECHANICAL ADVANTAGES. THE AUTHORS COMPARED SHORT-TERM OUTCOMES BETWEEN RG AND LG FOR PATIENTS WITH AND WITHOUT VISCERAL OBESITY. IN THE WHOLE COHORT, THE OVERALL COMPLICATION RATE WAS 13.0% FOR THE ROBOTIC GROUP, WHILE IN THE MATCHED COHORT, THE COMPLICATION RATE WAS HIGHER FOR RG. HOWEVER, THE INCIDENCE OF SEVERE COMPLICATIONS (CLAVIEN-DINDO GRADE III OR HIGHER) WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN RG AND LG IN EITHER COHORT. INTRA-ABDOMINAL INFECTIOUS COMPLICATIONS (IAICS) SUCH AS PANCREATIC FISTULA, ANASTOMOTIC LEAKAGE, AND INTRA-ABDOMINAL ABSCESSES WERE IDENTIFIED, WITH VISCERAL OBESITY BEING A SIGNIFICANT RISK FACTOR. ALTHOUGH THE ROBOTIC SYSTEM DID NOT DEMONSTRATE A CLEAR ASSOCIATION WITH INCREASED SPECIFIC COMPLICATIONS COMPARED TO LG, THE OVERALL COMPLICATION RATE WAS HIGHER IN THE ROBOTIC GROUP WITHIN THE MATCHED COHORT. NO DEATHS WERE REPORTED IN ASSOCIATION WITH THE ROBOTIC SYSTEM. WHILE THE STUDY COULD NOT ACCOUNT FOR PRECISE DIFFERENCES IN SURGEON SKILL LEVELS, ALL THREE SURGEONS INVOLVED WERE QUALIFIED UNDER THE JAPANESE SOCIETY'S ENDOSCOPIC SURGERY STANDARDS, AND TECHNICAL BIAS WAS MINIMIZED THROUGH PATIENT-MATCHING ANALYSIS. ONLY SHORT-TERM OUTCOMES WERE EVALUATED, SO THE LONG-TERM EFFECTS OF ROBOTIC SURGERY REMAIN UNCERTAIN. THE AUTHORS CONCLUDED THAT RG MAY BE A VIABLE ALTERNATIVE TO LG, PARTICULARLY IN PATIENTS WITH VISCERAL OBESITY DUE TO REDUCED POSTOPERATIVE IAIC RATES, THOUGH RG MAY NOT OFFER THE SAME BENEFITS FOR NON-VISCERALLY OBESE PATIENTS. THERE WERE NO REPORTS OF A DA VINCI DEVICE MALFUNCTION. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "353232284", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. CITATION: KUBO N, SAKURAI K, HASEGAWA T, TAMAMORI Y, ISEKI Y, NISHII T, SHIMIZU S, INUE T, NISHIGUCHI Y AND MAEDA K, (2023) IMPACT OF A ROBOTIC SYSTEM ON INTRA-ABDOMINAL INFECTIOUS COMPLICATIONS AFTER MINIMALLY INVASIVE GASTRECTOMY IN PATIENTS WITH GASTRIC CANCER: A PROPENSITY SCORE MATCHING ANALYSIS REGARDING VISCERAL OBESITY DOI: 10.1002/AGS3.12748." } ], "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": "" } ] }