{ "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": "2955842-2022-11021", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220413", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20220413", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2689499", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220413", "brand_name": "DA VINCI S/SI", "generic_name": "PATIENT SIDE CART, 4-ARM", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380430-03", "catalog_number": "380430", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": "", "date_changed": "20250807", "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": "20220413", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pneumonia", "Post Operative Wound Infection", "Hemorrhage/Blood Loss/Bleeding", "Pneumonia", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20220314", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14104770", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220314", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "294577135", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE POST-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED OR ARE UNKNOWN AT THIS TIME. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THERE WAS NO IMAGE OR VIDEO CLIP SUPPLIED FOR REVIEW RELATED TO A SPECIFIC EVENT. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿ROBOTIC TOTAL GASTRECTOMY FOR CARCINOMA IN THE REMNANT STOMACH: A COMPARISON WITH LAPAROSCOPIC TOTAL GASTRECTOMY,¿ IT IS NOTED THAT 8 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED TOTAL GASTRECTOMY PROCEDURES EXPERIENCED POST-OPERATIVE COMPLICATIONS. AT THIS TIME, THE CAUSES OF THESE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE COMPLICATIONS. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. FIELD IS BLANK BECAUSE THE EVEN DATE IS UNKNOWN. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN IS NOT AVAILABLE. FIELD IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "294577136", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 14-MAR-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A \"GASTROENTEROLOGY REPORT\" JOURNAL ARTICLE TITLED, ¿ROBOTIC TOTAL GASTRECTOMY FOR CARCINOMA IN THE REMNANT STOMACH: A COMPARISON WITH LAPAROSCOPIC TOTAL GASTRECTOMY¿ (LI, Z., LIU, J., ET AL., 2021). THE PURPOSE OF THE ARTICLE WAS TO COMPARE THE EFFICACY AND SAFETY OF ROBOTIC TOTAL GASTRECTOMY (RTG) AND LAPAROSCOPIC TOTAL GASTRECTOMY (LTG) FOR THE TREATMENT OF CARCINOMA IN THE REMNANT STOMACH (CRS). A RETROSPECTIVE ANALYSIS OF DATA FROM PATIENTS WHO UNDERWENT RTG OR LTG FOR CRS AT A SPECIFIED HOSPITAL BETWEEN MAY 2006 AND OCTOBER 2019 WAS CONDUCTED. ALL SURGERIES WERE PERFORMED BY ONE SURGEON. THE SURGEON PERFORMED A TOTAL OF 27 ROBOTIC GASTRECTOMIES (RG). THE SURGICAL METHOD OF ROBOTIC VERSUS LAPAROSCOPIC WAS SELECTED BY EACH PATIENT. THE DA VINCI SURGICAL SYSTEM WAS USED FOR 29 PATIENTS. FIVE CASES IN THE RTG GROUP UNDERWENT CONVERSION TO OPEN SURGERY. THE REASONS FOR CONVERSION TO OPEN SURGERY IN THE ROBOTIC GROUP INCLUDED 3 CASES OF EXTENSIVE ADHESIONS, 1 CASE OF TUMOR INVASION TO THE TRANSVERSE COLON, AND 1 CASE OF TUMOR INVASION TO THE DIAPHRAGM. POST-OPERATIVELY, 1 PATIENT EXPERIENCED PNEUMONIA, 1 HAD AN INTRA-ABDOMINAL INFECTION, AND 1 HAD A WOUND INFECTION. ADDITIONAL POST-OPERATIVE COMPLICATIONS INCLUDED 3 WITH ESOPHAGOJEJUNOSTOMY LEAKAGE, 1 WITH AN INTESTINAL LEAKAGE, AND 1 WHO EXPERIENCED AN INTRA-ABDOMINAL HEMORRHAGE. THERE WERE ZERO IN-HOSPITAL MORTALITIES IN THE ROBOTIC GROUP. ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }