{ "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": "2955842-2015-01531", "type_of_report": [ "Followup" ], "product_problem_flag": "", "date_received": "20151229", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20151130", "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": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20151229", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "857272", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151229", "brand_name": "DA VINCI XI 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": "IS4000", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20151229", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " L", " R" ], "patient_age": "80 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Injury" ] } ], "distributor_city": "", "date_report": "20151130", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5333088", "removal_correction_number": "", "number_devices_in_event": "", "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": "40594751", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 02/16/2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE OPERATIVE REPORT RELATED TO THE REPORTED EVENT FROM THE SITE'S RISK MANAGER. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON PERFORMED A LEFT ROBOTIC SURGERY WITH CONVERSION TO LEFT THORACOTOMY FOR ESOPHAGEAL DIVERTICULECTOMY, MYOTOMY, REPAIR OF AORTIC PERFORATION. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 2100 ML. AFTER THE ROBOT WAS DOCKED TO THE PATIENT, THE SURGEON NOTED THE FOLLOWING: THE INFERIOR PULMONARY LIGAMENT WAS DIVIDED TO THE LEVEL OF THE INFERIOR PULMONARY VEIN. THE PLEURA OVERLYING THE ESOPHAGUS WAS THEN OPENED WITH CARE TAKEN NOT TO INJURE THE VAGUS NERVES. THE ESOPHAGUS WAS DISSECTED DISTALLY TO PROXIMALLY. THE DIVERTICULUM WAS ACTUALLY PRESENT IN THE MID ESOPHAGEAL REGION AND THERE WAS INFLAMMATION AROUND THE DIVERTICULUM. WHILE DISSECTING THE DIVERTICULUM A SMALL PERFORATION WAS MADE IN THE AORTA AT THE LEVEL OF THE DIVERTICULUM. THE ROBOT WAS IMMEDIATELY UNDOCKED, AND A THORACOTOMY WAS PERFORMED. A RETRACTOR WAS PLACED AND THE AORTA WAS CLAMPED MANUALLY. AFTER ANESTHESIA ADMINISTERED PACKED RED BLOOD CELLS, THE SURGEON NOTED, THE AORTIC OPENING WAS CLOSED USING BUTTRESSED INTERRUPTED PROLENE SUTURES WITH PLEDGETS. THE AORTIC CROSSCLAMP WAS REMOVED AND AT THE AREA OF CLAMPING THERE WAS A LATERAL PERFORATION. THE CLAMP WAS THEN MOVED SUPERIORLY AND THIS SECOND OPENING WAS CLOSED, AGAIN WITH PLEDGETED PROLENES. THE SURGEON THEN PERFORMED THE DIVERTICULECTOMY. AFTER ALL CLOTTING WAS REMOVED, A VASCULAR SURGEON PLACED SEVERAL MORE PLEDGETED PROLENE SUTURES AT THE MORE PROXIMAL OPENING IN THE AORTA TO ACHIEVE HEMOSTASIS. SURGICEL AND THROMBIN WERE PLACED AND THE AREA WAS PACKED. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT IN CRITICAL CONDITION AND ON AN EPINEPHRINE DRIP. THERE IS NO DOCUMENTATION WITHIN THE OPERATIVE REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. PER A PROGRESS NOTE, THE PATIENT EXPERIENCED ACUTE RESPIRATORY FAILURE, HYPOVOLEMIC SHOCK-HEMORRHAGIC, ACUTE BLOOD LOSS ANEMIA, METABOLIC ACIDOSIS, AND CARDIAC ARREST STATUS-POST CPR. THIRTY MINUTES OF CPR WAS PERFORMED. THE PATIENT WAS PRONOUNCED DEAD AT 16:15 ON (B)(6) 2015. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED AN AORTIC INJURY AND SUBSEQUENTLY PASSED AWAY THE SAME DAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEATH ARE UNKNOWN. ALSO, THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "34645242", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSES FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO ALLEGATION FROM THE SURGICAL STAFF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE SURGEON ALLEGEDLY INJURED A VESSEL WHICH WAS REPAIRED. HOWEVER, THE PATIENT PASSED AWAY LATER THAT SAME DAY. AT THIS TIME, THE CAUSES OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE ARE UNKNOWN." }, { "mdr_text_key": "34645243", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGEAL DIVERTICULUM REPAIR AND MYOTOMY PROCEDURE, THE SURGEON ALLEGEDLY HIT THE PATIENT'S AORTA AND THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT REPORTEDLY PASSED AWAY SHORTLY AFTER IN THE ICU. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE REPORTED EVENT OCCURRED ABOUT AN HOUR AFTER THE SURGEON HAD BEEN SITTING AT THE SURGEON SIDE CONSOLE (SSC). AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS PERFORMING DISSECTION AND WAS USING A MARYLAND BIPOLAR FORCEPS INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO ALLEGATION FROM THE SURGICAL STAFF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A DAY AFTER THE EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON. THE SURGEON DID NOT PROVIDE A POSSIBLE CAUSE TO THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. HOWEVER, THE CSR INDICATED THAT SHE SPOKE TO A SURGICAL ASSISTANT WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGICAL ASSISTANT INFORMED HER THAT THE SURGEON NICKED THE AORTA OR A VESSEL COMING OFF OF THE AORTA. AFTER THE VESSEL INJURY OCCURRED, THE SURGEON MADE THE DECISION TO IMMEDIATELY CONVERT TO OPEN SURGERY IN ORDER TO CONTROL BLEEDING THAT ENSUED. THE SURGEON REPAIRED THE VESSEL DEFECT WITH SUTURES. THE SURGICAL ASSISTANT DESCRIBED THE VESSEL DEFECT AS BEING THE WIDTH OF THE SURGEON'S FINGER. A VASCULAR SURGEON CAME INTO THE OR AND ADDED ADDITIONAL SUTURES TO THE VESSEL DEFECT. THE PATIENT PASSED AWAY IN THE ICU THE SAME DAY THE EVENT OCCURRED. THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN AT THIS TIME." } ], "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": "03/17/2016" } ] }