{ "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": "Injury", "report_number": "2955842-2014-01168", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140226", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120409", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140227", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "118465", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140226", "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": "", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20140226", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "81 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Laceration(s)", "Cardiogenic Shock", "Respiratory Acidosis", "Respiratory Failure", "Low Cardiac Output" ] } ], "distributor_city": "", "date_report": "20140128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3648520", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140128", "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": "17570961", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI CORONARY ARTERY BYPASS PROCEDURE FOR STENT STENOSIS ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED THE PATIENT'S HOSPITAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. BASED ON THE OPERATIVE REPORT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN ELECTIVE CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2012. THE PATIENT WAS INFORMED OF THE RISK, BENEFITS, AND ALTERNATIVES TO THE PROCEDURE. THE PATIENT UNDERSTOOD, AGREED, AND WISHED TO PROCEED WITH THE PROCEDURE. ACCORDING TO THE OPERATIVE REPORT, DURING AN INSTRUMENT CHANGE FOR THE SUPERIOR ROBOTIC PORT AN INADVERTENT AORTIC INJURY WAS CREATED. THIS APPEARED TO SELF TAMPONADE, HOWEVER, PRUDENCE DICTATED CONVERSION TO OPEN AT THIS POINT. THEREFORE, THE ROBOT WAS REMOVED FROM THE FIELD. THE LEFT ANTERIOR THORACOTOMY WAS MADE TO INCLUDE THE THORACOSCOPIC PORT. IN ADDITION IT WAS NOTED THAT, A SMALL LINEAR RENT ON THE OUTER SURFACE OF THE DESCENDING AORTA SUPERIOR TO THE PULMONARY ARTERY WAS IDENTIFIED CONSISTENT WITH THE INJURY FROM INSTRUMENT SWAP. A SUTURE WAS USED TO REPAIR THE TEAR AND EXCELLENT HEMOSTATIC OUTCOME WAS NOTED. AS THE MAMMARY COULD NOT BE CLEARLY VISUALIZED FROM THE THORACOTOMY, THE OPERATION WAS CONVERTED TO A STERNOTOMY. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, HEMOSTASIS WAS ACHIEVED THROUGHOUT THE CHEST WITH CAREFUL SURVEY OF THE PREVIOUS REPAIRED AORTIC INJURY AND OTHER PARTS WERE MADE SURE TO BE HEMOSTATIC. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED IN CRITICAL BUT STABLE CONDITION TO THE INTENSIVE CARE UNIT (ICU). POSTOPERATIVELY, THE PATIENT DEVELOPED ACIDOSIS AND LOW CARDIAC OUTPUT SYNDROME. A POSTOPERATIVE ECHOCARDIOGRAM SHOWED AN EJECTION FRACTION OF 60% WITH NO EVIDENCE OF TAMPONADE OR ONGOING BLEEDING. ULTIMATELY THE PATIENT EXPIRED FROM RESPIRATORY FAILURE AND POSTOPERATIVE CARDIOGENIC SHOCK. AN AUTOPSY REPORT SHOWED THE CAUSE OF DEATH AS CARDIAC AND RESPIRATORY FAILURE FOLLOWING CORONARY ARTERY BYPASS GRAFTING DUE TO ATHEROSCLEROTIC CORONARY ARTERY DISEASE. THE MANNER OF DEATH WAS NATURAL." }, { "mdr_text_key": "17712993", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012. NO SYSTEM RELATED ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED AN INTRA-OPERATIVE COMPLICATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY." } ], "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": "" } ] }