{ "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": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Death", "report_number": "2955842-2024-14461", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240509", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240418", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20240509", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231218", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1330854", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240509", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-50", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/18/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20240509", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "68 YR", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Embolism", "Dyspnea", "Asystole", "Respiratory Arrest", "Pulmonary Embolism", "Dyspnea", "Asystole", "Respiratory Arrest" ] } ], "distributor_city": "", "date_report": "20240419", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19275052", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240419", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "342083371", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT DIED OF A PULMONARY EMBOLISM ON AN UNSPECIFIED DATE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT HAD A FAST INITIAL POST-OPERATIVE RECOVERY. THE SURGEON AND THE HOSPITAL TEAM DO NOT THINK THIS IS DIRECTLY RELATED TO THE DA VINCI SINGLE PORT (SP) SYSTEM USED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON AND A RESPONSE IS PENDING." }, { "mdr_text_key": "342083372", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REVIEW OF THE SYSTEM LOGS FOUND NO ERRORS OCCURRED DURING THE PROCEDURE. LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM FOUND NO ERRORS OCCURRED THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE DEVICE(S) USED DURING THE PROCEDURE AND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS EVENT. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: 30 DEGREE ENDOSCOPE PLUS, SYNCHROSEAL, TIP-UP FENESTRATED GRASPER, FORCE BIPOLAR, SUREFORM 60, MONOPOLAR CURVED SCISSORS, CADIERE FORCEPS, MEGA SUTURECUT NEEDLE DRIVER. A SITE HISTORY REVIEW SHOWS NO COMPLAINTS HAVE BEEN REPORTED FOR ANY OF THESE PRODUCTS. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THE PATIENT DIED FOLLOWING A SINGLE PORT PROSTATECTOMY PROCEDURE. A PULMONARY EMBOLISM WAS DETERMINED TO BE THE CAUSE OF DEATH. THE EVENTS LEADING TO THE DEATH ARE UNKNOWN. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT." }, { "mdr_text_key": "349825805", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED: POST-OPERATION, THE PATIENT COLLAPSED AND WAS BRIEFLY UNCONSCIOUS. THEY BECAME RESPONSIVE WITH SYMPTOMS OF SIGNIFICANT DYSPNEA AND A RIGHT BUNDLE BRANCH BLOCK. OXYGEN WAS PROVIDED, AND CIRCULATORY STABILIZATION WITH ADMINISTRATION OF FLUIDS AND EPINEPHRINE WITHOUT SUCCESS. THE PATIENT WENT INTO CARDIAC ARREST, CPR WAS STARTED AND THE PATIENT WAS INTUBATED. THE PATIENT WAS TRANSPORTED TO THE SHOCK ROOM AND EMERGENCY THROMBOLYSIS AGENT WAS ADMINISTERED. SIXTY MINUTES AFTER ADMINISTRATION OF THROMBOLYSIS, RESUSCITATION ATTEMPTS WERE STOPPED DUE TO THERAPY-RESISTANT PULSELESS ELECTRICAL ACTIVITY/ASYSTOLE. THE SURGEON STATED THAT THEY DO NOT SEE ANY RELATIONSHIP BETWEEN THE CAUSE OF THE EMBOLISM AND THE DA VINCI SINGLE PORT SYSTEM. THE EMBOLISM IS BEING ATTRIBUTED TO THE GENERAL RISK OF SURGERY. THE HOSPITAL'S MEDICAL ANALYSIS DETERMINED THERE WAS NO INDICATION OF A GAS EMBOLISM." }, { "mdr_text_key": "349825806", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/21/2024" } ] }