{ "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": "I", "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": "2955842-2021-10752", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20210706", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "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": [ "HEALTH PROFESSIONAL", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210706", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1022816", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210706", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "380601-34", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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", "Insufficient Device Problem Information", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20210706", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20210611", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12125108", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210611", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "260200470", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED EVENT CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. PERFORMED A REVIEW OF ALL COMPLAINTS SUBMITTED BY THE SITE SINCE (B)(6) 2019 - THE DATE ON WHICH THE DA VINCI SP SYSTEM WAS INSTALLED AT THE SITE. WHILE SOME SP SYSTEM COMPLAINT RECORDS WERE LOCATED, THE SEARCH RESULTS DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS KNOWN TO BE RELATED TO THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. NO MEDICAL REVIEW WAS POSSIBLE AT THIS TIME AS THERE IS NO MEDICAL/CLINICAL DETAIL ON FILE FOR REVIEW. THERE WAS NO REPORT OR KNOWN ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DAVINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THE REPORTED EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE MALFUNCTION. HOWEVER, THERE WAS A REPORT OF A PATIENT DEATH OCCURRING ON A DA VINCI SYSTEM BUT ADDITIONAL EVENT DETAILS, PATIENT DEMOGRAPHICS AND PATIENT DATE OF DEATH, AND SYSTEM AND/OR PROCEDURE DETAILS WERE UNKNOWN. AT THIS TIME, THE ROOT CAUSE OF THE PATIENT¿S DEATH IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE (2020 REPORTS) IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN INITIAL REPORTER NAME AND ADDRESS IS NOT AVAILABLE. INITIAL REPORTER ALSO SENT REPORT TO FDA? IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. TYPE OF REPORT, ADVERSE EVENT, RECALL (IF RECALL NUMBER IS GIVEN) (2020 REPORTS), AND CORRECTION/REMOVAL NUMBER (2020 REPORTS) ARE NOT APPLICABLE." }, { "mdr_text_key": "260200471", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED BY AN UNSPECIFIED SURGEON, NOT THE CONSOLE SURGEON OF RECORD, THAT THERE WAS A REPORT OF A PATIENT DEATH OCCURRING ON AN SP DA VINCI SYSTEM. ADDITIONAL EVENT DETAILS (INCLUDING THE DATE OF THE EVENT), PATIENT DEMOGRAPHICS, PATIENT DATE OF DEATH, AND SYSTEM AND/OR PROCEDURE DETAILS WERE UNKNOWN AND UNATTAINABLE EVEN AFTER ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION. INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." } ], "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": "" } ] }