{ "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": "HOSPITAL", "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": "Death", "report_number": "2955842-2013-05401", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131122", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131022", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131125", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "609107", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131122", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20131122", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Perforation of Esophagus" ] } ], "distributor_city": "", "date_report": "20131025", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3484740", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140113", "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": "4017731", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION AND CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE SUSTAINED AN ESOPHAGEAL PERFORATION ON POST-OP DAY 1. ON (B)(6) 2013, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE FIRST HALF OF THE SURGICAL PROCEDURE. DURING THE TIME THE CSR WAS PRESENT DURING THE CASE, SHE DID NOT WITNESS ANY INTRA-OPERATIVE COMPLICATIONS OR ISSUES WITH THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2013, THE CSR STATED THAT SHE SPOKE TO THE SURGEON AND WAS TOLD THAT THE PATIENT HAD PASSED AWAY. THE DATE AND CAUSE OF THE PATIENT'S DEMISE WAS NOT PROVIDED BY THE SURGEON. THE CSR INDICATED THAT THE SURGEON INFORMED HER THAT SHE FELT AS THOUGH THE DA VINCI SURGICAL PROCEDURES WENT WELL. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CSR." }, { "mdr_text_key": "11349311", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT AND THE PATIENT'S SUBSEQUENT DEMISE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGER FROM THE SITE. THE RISK MANAGER INDICATED THAT SHE COULD NOT PROVIDE ANY INFORMATION REGARDING THE REPORTED EVENT DUE TO PATIENT CONFIDENTIALITY REGULATIONS. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(4) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED AN ESOPHAGEAL PERFORATION AND SUBSEQUENTLY PASSED AWAY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S ESOPHAGEAL INJURY AND DEMISE ARE UNKNOWN." }, { "mdr_text_key": "11425812", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON INVOLVED WITH THIS COMPLAINT. THE SURGEON STATED THAT THE DA VINCI SURGICAL PROCEDURE WENT FINE AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. BASED ON HER RECORDS, THE DA VINCI SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2013. THE FOLLOWING DAY ((B)(6) 2013), THE PATIENT WAS FOUND TO HAVE AN ESOPHAGEAL PERFORATION. ON (B)(6) 2013, A THORACIC SURGEON PLACED AN ESOPHAGEAL STENT INTO THE PATIENT. ACCORDING TO THE SURGEON, THE PATIENT PASSED AWAY ON (B)(6) 2013 DUE TO SEPSIS AND MULTIPLE ORGAN FAILURE. THE SURGEON DID NOT KNOW THE CAUSE OF THE ESOPHAGEAL PERFORATION. THE SURGEON INDICATED THAT THE ESOPHAGEAL INJURY COULD HAVE BEEN DUE TO DEVASCULARIZATION POST-SURGERY OR SOMETHING THAT OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE THAT WAS NOT NOTICED." } ], "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": "01/17/2014" } ] }