{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2021-11175", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20210923", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20210923", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1415316", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210923", "brand_name": "DA VINCI", "generic_name": "PATIENT SIDE CART", "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": "UNKNOWN", "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": "", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20210923", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Respiratory Tract Infection", "Nervous System Injury", "Failure to Anastomose", "Respiratory Tract Infection", "Nervous System Injury" ] } ], "distributor_city": "", "date_report": "20210830", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12519465", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210830", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "273200181", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO INITIAL REPORT OR 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 INCIDENTS. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. ISI HAS ATTEMPTED TO FOLLOW-UP TO GATHER ADDITIONAL INFORMATION. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SITE HISTORY COMPLAINT REVIEW WAS UNABLE TO BE CONDUCTED AS THE PROCEDURE DETAILS ARE UNKNOWN. A SYSTEM LOG REVIEW CANNOT BE PERFORMED AT THIS TIME SINCE THE EVENT DATES, SITE NAME, AND DA VINCI SYSTEM INFORMATION ARE UNKNOWN. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE, VARIOUS COMPLICATIONS ASSOCIATED WITH ROBOTIC PROCEDURES WERE NOTED. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE COMPLICATIONS AS WELL AS THE MEDICAL/ SURGICAL INTERVENTION RENDERED, IF ANY, ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/ CONTRIBUTED TO THE OPERATIVE COMPLICATIONS. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. MULTIPLE PRODUCT INFORMATION ARE UNKNOWN DUE TO LIMITED PRODUCT INFORMATION BEING PROVIDED. DUE TO LACK OF PRODUCT INFORMATION (510K NO.), AND (MFG DATE) ARE NOT AVAILABLE. THE EVENT DATE IS UNKNOWN. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA." }, { "mdr_text_key": "273200182", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ANNALS OF TRANSLATIONAL MEDICINE ARTICLE TITLED, ¿RISK FACTORS FOR LYMPH NODE METASTASIS OF THE LEFT RECURRENT LARYNGEAL NERVE IN PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA¿ (CHEN, C., MA, Z., SHANG, X. ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: \"THERE WERE 6 CASES WITH VOCAL CORD PARALYSIS (16.38%), 3 WITH ANASTOMOTIC LEAKAGE (3.19%), AND 10 WITH PULMONARY INFECTION (10.64%) AFTER ESOPHAGECTOMY.\" ADDITIONAL INFORMATION OBTAINED FROM THE JOURNAL ARTICLE: THIS WAS A RETROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT MCKEOWN MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) (NO NEOADJUVANT THERAPY) AT TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL (FROM JANUARY 2016 TO DECEMBER 2019). DA VINCI ROBOT-ASSISTED (DA VINCI SI/XI) AND THORACIC LAPAROSCOPIC VIDEO-ASSISTED MIE WERE PERFORMED IN 3 STAGES. FIRST, THORACOSCOPY OR THE DA VINCI ROBOT WAS USED TO MOBILIZE THE ESOPHAGUS AND DISSECT THE THORACIC LNS IN THE PRONE POSITION WITH THE RIGHT HAND HOLDING THE HEAD. SECOND, THORACOSCOPY OR THE DA VINCI ROBOT WAS USED TO CREATE THE GASTRIC CONDUIT AND DISSECT THE ABDOMINAL LNS IN THE SUPINE POSITION. FINALLY, A LEFT CERVICAL NECK INCISION WAS MADE TO CREATE A CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS. THE DETECTION OF LEFT RLN LNS USING ENHANCED COMPUTED TOMOGRAPHY (CT) WAS COMPARED WITH THE PATHOLOGICAL EXAMINATION. OF THE TOTAL 94 PARTICIPANTS, 43 HAD LN METASTASIS. THE METASTATIC LNS WERE MAINLY LOCATED NEXT TO LEFT (18.1%) AND RIGHT (14.9%) RLN, AND THE LEFT GASTRIC ARTERY (13.8%). THE SIZE OF LEFT RLN LN IS INDEPENDENTLY ASSOCIATED WITH METASTASIS. LEFT RLN LNS >5.5 MM AT CT EXAMINATION IS MORE LIKELY TO BE POSITIVE AND SHOULD PROBABLY BE DISSECTED. ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. AT THIS TIME, THE ROOT CAUSE OF THE ALLEGED ISSUE IS UNKNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }