{ "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": "2955842-2021-11500", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20211113", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20211113", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1706647", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211113", "brand_name": "DA VINCI", "generic_name": "DAVINCI 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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "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": "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": "20250808", "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": "20211113", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Obstruction/Occlusion", "Stenosis of the esophagus", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "Obstruction/Occlusion", "Stenosis of the esophagus", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available" ] } ], "distributor_city": "", "date_report": "20211015", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12808154", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211015", "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": "280816928", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE IS NO ALLEGATION FROM THE JOURNAL ARTICLE AUTHOR, OR ANY KNOWN ALLEGATION FROM A MEDICAL PROFESSIONAL, OF A SPECIFIC DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. A SITE HISTORY COMPLAINT REVIEW WAS UNABLE TO BE CONDUCTED AS THE PROCEDURE DATES ARE UNKNOWN AND SITE DETAILS ARE UNCONFIRMED. UNABLE TO CONDUCT SYSTEM OR INSTRUMENT LOG REVIEW DUE TO LACK OF SITE, SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: WITHIN THE JOURNAL OF GASTRIC CANCER ARTICLE TITLED, \"INTRACORPOREAL ESOPHAGOJEJUNOSTOMY DURING REDUCED-PORT TOTALLY ROBOTIC GASTRECTOMY FOR PROXIMAL GASTRIC CANCER: A NOVEL APPLICATION OF THE SINGLE-SITE®PLUS 2-PORT SYSTEM,\" A NUMBER OF PATIENTS UNDERWENT DA VINCI-ASSISTED SURGICAL PROCEDURES AND EXPERIENCED POST-OPERATIVE COMPLICATIONS WHICH REQUIRED MEDICAL INTERVENTION. ALTHOUGH THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, THE CAUSES OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN." }, { "mdr_text_key": "280816929", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 15-OCT-2021, INTUITIVE BECAME AWARE OF A JOURNAL OF GASTRIC CANCER ARTICLE TITLED, \"INTRACORPOREAL ESOPHAGOJEJUNOSTOMY DURING REDUCED-PORT TOTALLY ROBOTIC GASTRECTOMY FOR PROXIMAL GASTRIC CANCER: A NOVEL APPLICATION OF THE SINGLE-SITE® PLUS 2-PORT SYSTEM\" (CHOI, S., SON, T., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: \"ANASTOMOSIS-RELATED COMPLICATIONS WERE OBSERVED IN 2 PATIENTS. THE PATIENT WAS DISCHARGED ON POD 6 AFTER PROXIMAL GASTRECTOMY AND WAS RE-ADMITTED 14 DAYS AFTER DISCHARGE. THE PATIENT DEVELOPED ESOPHAGOJEJUNOSTOMY LEAKAGE, WHICH WAS TREATED WITH ENDOSCOPIC STENT INSERTION. ANOTHER PATIENT DEVELOPED ESOPHAGOJEJUNOSTOMY SITE STENOSIS THAT REQUIRED ENDOSCOPIC DILATATION DURING HOSPITALIZATION, AFTER WHICH THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY (POD) 29. THE OTHER PATIENT WHO UNDERWENT COMPLETION TOTAL GASTRECTOMY DEVELOPED AN INTESTINAL OBSTRUCTION THAT REQUIRED ADDITIONAL SURGERY (LAPAROSCOPIC SEGMENTAL RESECTION OF THE SMALL BOWEL), AFTER WHICH THE PATIENT WAS DISCHARGED ON POD 35.\" INTUITIVE SURGICAL, INC. (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": "" } ] }