{ "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": "2955842-2010-00461", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20101025", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Invalid data", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20101027", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20101025", "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": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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" } } ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20101025", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20100926", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1882150", "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": "1835435", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WHILE GATHERING INFORMATION FOR A STUDY, THE SURGEON WAS MADE AWARE OF 3 EVENTS THAT OCCURRED 4 TO 7 DAYS POST A DA VINCI S TORS PROCEDURE WHERE THE PATIENT EXPIRED SECONDARY TO COMPLICATION RELATED TO THEIR CANCER. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. FOR THESE SIMILAR EVENTS, PLEASE SEE MDR'S 2955842-2010-00460 AND 2955842-2010-00462." }, { "mdr_text_key": "2015002", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6), 2011, THE INITIAL REPORTER PROVIDED ADDITIONAL INFORMATION RELATED TO THIS EVENT. HE ADVISED THAT THE PATIENT UNDERWENT A DA VINCI S PARTIAL LARYNGECTOMY PROCEDURE AND EXPERIENCED BLEEDING FROM THE LARYNGEAL ARTERY 7 DAYS POST OP. THE PATIENT HAD ASPIRATED BLOOD AND A SECONDARY SURGERY WAS PERFORMED TO SUCCESSFULLY CONTROL THE BLEEDING. THE PATIENT WAS INTUBATED AND EXPIRED 1 TO 2 DAYS LATER DUE TO A CHEST INFECTION FROM THE ASPIRATION. THE INITIALS REPORTER ADVISED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM." }, { "mdr_text_key": "8890170", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SURGEON HAS INDICATED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED AND NO SYSTEM MALFUNCTIONS OCCURRED. AS OF OCTOBER 22, 2010, NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO INTUITIVE SURGICAL. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "17194712", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON DID NOT SPECIFY WHAT TYPE OF CANCER THIS PATIENT WAS DIAGNOSED WITH; HOWEVER, DID ADVISE THAT THE CANCER WAS NEITHER A T3 OR T4. THIS INFORMATION IS BEING PROVIDED TO CLARIFY INFORMATION PROVIDED IN A FOLLOW UP REPORT TO THE FDA ON (B)(6) 2011." } ], "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": "10/27/2010;06/10/2011;06/10/2011" } ] }