{ "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": "2955842-2014-00356", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140117", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121016", "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": "20140117", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "45314", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140117", "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": "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": "20140117", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Arrhythmia", "Death", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Myocardial Infarction", "Occlusion" ] } ], "distributor_city": "", "date_report": "20131126", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3582490", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131126", "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": "19294437", "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 ROBOTIC ADRENALECTOMY PROCEDURE FOR A VERY LARGE ADRENAL MASS ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP HOSPITAL RECORDS AND DEATH SUMMARY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 PATIENT UNDERWENT ROBOTIC ADRENALECTOMY. THE ADRENAL GLAND WAS NEARLY DETACHED WHEN AN EXCESSIVE AMOUNT OF BLEEDING WAS NOTED TO BE COMING FROM THE INFERIOR VENA CAVA. THEORETICALLY THE ADRENAL VEIN RUPTURED OR WAS TORN FROM THE IVC. EXCESSIVE BLEEDING ENSUED BUT WAS ULTIMATELY CONTROLLED BY PLACING A HAND PORT. A VASCULAR SURGEON WAS SUMMONED AND ARRIVED. AN IVC REPAIR WAS UNDERTAKEN AND ACCOMPLISHED VIA LAPAROTOMY. INTRAOPERATIVELY THE PATIENT BECAME HYPOTENSIVE AND SUFFERED CONSEQUENCES DESPITE RECEIVING A BLOOD TRANSFUSION. A MYOCARDIAL INFARCTION OCCURRED FOLLOWED BY A SEVERE ARRHYTHMIA. ON (B)(6) 2012, A CARDIAC CATHETERIZATION WAS PERFORMED WHICH SHOWED COMPLETE OCCLUSION OF THE CORONARY ARTERIES. ON (B)(6) 2012, THE PATIENT GRADUALLY BECAME MORE HYPOTENSIVE AND ULTIMATELY EXPIRED WITHOUT RESUSCITATIVE EFFORT ACCORDING TO THE WISHES OF THE FAMILY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "19394685", "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 POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER DEATH. 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 ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S OPERATIVE REPORTS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY DIED ON (B)(6) 2012." } ], "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": "" } ] }