{ "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": "2955842-2013-00538", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130216", "manufacturer_address_2": "", "pma_pmn_number": "", "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": [ "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130219", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "69822", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130216", "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": "0", "model_number": "", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20130216", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "49 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Sepsis", "Brain Injury", "Bowel Perforation", "Multiple Organ Dysfunction Syndrome" ] } ], "distributor_city": "", "date_report": "20130117", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2966014", "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": "3137503", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IN A PUBLISHED CITRON RESEARCH ARTICLE TITLED INTUITIVE SURGICAL: ANGEL WITH BROKEN WINGS, OR DEVIL IN DISGUISE? ON JANUARY 17, 2013, IT WAS STATED ON PAGE 22 IN AN EMBEDDED ARTICLE LINK (CHICAGO DAILY LAW BULLETIN - FAMILY GETS $7.5 MILLION IN DEATH AFTER SPLEEN REMOVAL) THAT A (B)(6) MAN DIED ONE MONTH AFTER A DA VINCI SURGERY TO REMOVE HIS SPLEEN IN 2007. ALLEGEDLY, THE DECEDENT UNDERWENT THE SURGERY BECAUSE HE SUFFERED FROM A DISORDER THAT PREVENTED HIS BLOOD FROM PROPERLY CLOTTING. THE DECEDENT ALLEGEDLY SUFFERED TWO HOLES IN HIS DUODENUM, AN ORGAN THAT IS 6 TO 10 INCHES FROM THE SPLEEN. FURTHERMORE, ACCORDING TO THE ARTICLE, HE BECAME SICK AND DEVELOPED SEPSIS THAT CAUSED SEVERAL ORGANS TO FAIL POST-SURGERY. IT WAS ALSO ALLEGED THAT HE SUFFERED BRAIN DAMAGE AND DIED IN (B)(6) 2007. A MEDICAL-MALPRACTICE LAWSUIT WAS FILED AGAINST FOUR DOCTORS OF THE (B)(6) -BASED HOSPITAL, WHO REPORTEDLY DENIED THE ALLEGATION THAT THE DUODENUM HOLES OCCURRED DURING THE SURGERY. INTUITIVE SURGICAL WAS NOT NAMED AS A DEFENDANT IN THIS LAWSUIT. THESE ALLEGATIONS WERE NOT PREVIOUSLY REPORTED TO INTUITIVE SURGICAL AND HAVE NOT BEEN SUBSTANTIATED. ANY FURTHER INFORMATION RECEIVED BY THE COMPANY WILL BE PROVIDED VIA A FOLLOW UP MDR." }, { "mdr_text_key": "10511958", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL WAS NOT ABLE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "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": "" } ] }