{ "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": "2955842-2024-18183", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240814", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240215", "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": "", "manufacturer_contact_area_code": "408", "date_added": "20240814", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1164185", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240814", "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": "20250820", "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": "20240814", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "66 YR", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Unspecified Gastrointestinal Problem", "Fistula", "Unspecified Gastrointestinal Problem" ] } ], "distributor_city": "", "date_report": "20240717", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19987710", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240717", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "349333685", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A CLINICAL ARTICLE WAS CONDUCTED BASED ON A RETROSPECTIVE STUDY EVALUATING THE SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE GASTRECTOMY IN PATIENTS WITH ADVANCED GASTRIC CANCER WHO HAD UNDERGONE PREOPERATIVE CHEMOTHERAPY. THE STUDY, WHICH ANALYZED 150 CASES FROM JANUARY 2009 TO MARCH 2022, FOCUSED ON BOTH DA VINCI ROBOTIC AND LAPAROSCOPIC GASTRECTOMY APPROACHES. THE RESULTS DEMONSTRATED THAT MINIMALLY INVASIVE PROCEDURES, PARTICULARLY ROBOTIC GASTRECTOMY, WERE FEASIBLE AND SAFE, WITH MINIMAL BLOOD LOSS (72 GRAMS) AND MANAGEABLE COMPLICATIONS. NOTABLY, CONVERSION SURGERY WAS PERFORMED IN 41 CASES (27.3%), AND PANCREATIC FISTULA WAS THE MOST COMMON COMPLICATION, OCCURRING IN 11 PATIENTS. POSTOPERATIVE COMPLICATIONS (GRADE > OR = 3A) WERE OBSERVED IN 18 PATIENTS. THE STUDY ACKNOWLEDGED LIMITATIONS, INCLUDING ITS RETROSPECTIVE DESIGN, SMALL SAMPLE SIZE, AND SHORT FOLLOW-UP PERIOD. OVERALL, ROBOTIC GASTRECTOMY SHOWED POTENTIAL FOR IMPROVED SURGICAL SAFETY, ESPECIALLY IN COMPLEX CASES INVOLVING SPLENECTOMY, AND FURTHER INVESTIGATION IS NEEDED TO REFINE TREATMENT STRATEGIES AND ASSESS LONG-TERM OUTCOMES. THE RESEARCHERS DID NOT REPORT ANY SPECIFIC MALFUNCTIONS OR INJURIES RELATED TO INTUITIVE SURGICAL, INC. (ISI) DEVICES." }, { "mdr_text_key": "349333686", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MEDWATCH REPORT REFLECTS ADVERSE EVENT-ONLY DATA FROM A LITERATURE ARTICLE. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. ADDITIONALLY, THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. THE DESIGNATED AUTHOR WAS CONTACTED FOR ADDITIONAL INFORMATION UNSUCCESSFULLY. SOURCE: SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE GASTRECTOMY FOLLOWING PREOPERATIVE CHEMOTHERAPY FOR HIGHLY ADVANCED GASTRIC CANCER (SUDA, K. ET AL., 2024) BMC GASTROENTEROLOGY (2024) 24:74; HTTPS://DOI.ORG/10.1186/S12876-024-03155-5 BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE PATIENT DEMOGRAPHICS SECTION UTILIZED MEDIAN AGE AND WEIGHT DUE TO THE UNAVAILABILITY OF SPECIFIC INFORMATION IN THE LITERATURE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD E1-THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE FIRST AUTHOR'S ASSOCIATED HOSPITAL. WHILE THE EXACT SITE IS UNKNOWN, THIS DESIGNATION IS CONSIDERED APPROPRIATE SUBSTITUTION. DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED HAS BEEN USED." } ], "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": "" } ] }