{ "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": "", "report_to_fda": "N", "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": "2955842-2008-00038", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080125", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20070716", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NOT APPLICABLE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20080207", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080125", "brand_name": "DA VINCI S 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": "US", "manufacturer_d_postal_code": "*", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P2", "catalog_number": "*", "lot_number": "*", "other_id_number": "*", "device_availability": "Yes", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "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": [ "Unknown (for use when the device problem is not known)" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20080125", "sequence_number_treatment": [ "DA VINCI S SURGICAL SYS INSTRUMENTS", " ACCESSORIES" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "*", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dural Tear", "Bleeding", "Death", "Rupture", "Surgical procedure, additional" ] } ], "distributor_city": "", "date_report": "20080125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "991415", "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": "786054", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDWATCH UF/IMPORTER REPORT WAS REC'D AT ISI ON SEPTEMBER 28, 2007. INTUITIVE SURGICAL WAS PREVIOUSLY INFORMED OF THIS EVENT ON JULY 25, 2007. IT WAS ALSO REPORTED THAT THE PT WAS LATER BROUGHT BACK TO THE OR IN 2007, TO DRAIN CLOTS WHICH HAD FORMED, HOWEVER, THE DA VINCI SYS WAS NOT USED FOR THIS PROCEDURE. THE PT DIED FOUR DAYS POST DA VINCI ASSISTED SURGERY." }, { "mdr_text_key": "8050332", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON AUGUST 17, 2007, INTUITIVE SURGICAL SPOKE TO THE PHYSICIAN WHO PERFORMED THE PROCEDURE. THE PHYSICIAN INDICATED THAT THE PT LACERATION (THE TEAR AT THE LEFT ATRIUM) COULD HAVE OCCURRED BY A NUMBER OF DIFFERENT CAUSES. THE PHYSICIAN ALSO INDICATED THAT THE PT DIED OF SEVERE HEART FAILURE AND PULMONARY EDEMA, HOWEVER, THE PHYSICIAN DOES NOT BELIEVE THAT THE PT DEATH WAS RELATED TO THE LACERATION OR REPAIR. NO MALFUNCTION OF THE SYS WAS ALLEGED BY THE HOSP. ON JANUARY 22, 2008, A HOSP REP INDICATED THAT NO CONCLUSION CAN BE DRAWN REGARDING ANY ASSOCIATION WITH THE PT LACERATION AND THE ADD'L PROCEDURE PERFORMED IN 2007, AS DECREASED FUNCTION AND LEFT VENTRICULAR FAILURE IS A POSSIBILITY WITH ANY CARDIAC SURGERY, REGARDLESS OF A LACERATION. PER CUSTOMER REQUEST ONE MONTH LATER, AN INTUITIVE SURGICAL FIELD ENGINEER TESTED THE SYS AND VERIFIED THE SYS WAS OPERATING WITHIN NORMAL SPECS. NO ISSUES WITH THE SYS WERE FOUND AND THE SYS WAS VERIFIED FOR NORMAL OPERATION. THE HOSP HAS CONTINUED TO USE THE DA VINCI SYS TO PERFORM SURGERY ON PTS. AS OF THE DATE OF THIS REPORT, NO ADVERSE EVENTS OR PROD PROBLEMS HAVE BEEN EXPERIENCED WITH THE SITE'S DA VINCI SYS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS 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": "" } ] }