{ "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": "Injury", "report_number": "2955842-2024-14551", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240514", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240416", "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": "SZ", "manufacturer_contact_area_code": "408", "date_added": "20240514", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231206", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "707786", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240514", "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": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250820", "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": "20240514", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " L", " H" ], "patient_age": "76 YR", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Pulmonary Embolism", "Failure to Anastomose", "Pulmonary Embolism" ] } ], "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": "19315403", "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": "342505164", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE DEVICE(S) INVOLVED WITH THIS REPORTED EVENT: NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. NO RELEVANT ERRORS WERE OBSERVED IN THE SYSTEM LOGS FOR THIS PROCEDURE. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT USED DURING THIS PROCEDURE HAS BEEN REUSED. THE FOLLOWING OTHER INSTRUMENTS USED THIS PROCEDURE HAVE NOT BE USED IN SUBSEQUENT PROCEDURES: 0 DEGREE ENDOSCOPE, CADIERE FORCEPS, MONOPOLAR CURVED SCISSORS, NEEDLE DRIVER. A SITE HISTORY REVIEW SHOWS THE 0 DEGREE ENDOSCOPE USED DURING THIS PROCEDURE HAS A RETURN REQUEST CREATED FOR IT DUE TO ¿THE SWAB FOR VALIDATION WAS NOT GOOD.¿ ." }, { "mdr_text_key": "342505165", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE PATIENT HAD A POST-OPERATIVE PULMONARY EMBOLISM; THE SURGEON OF THE PROCEDURE REPORTED THAT THE PATIENT ALMOST DIED. THE PROCEDURE WAS FOUR HOURS LONG AND WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON SAID THE EMBOLISM WAS NOT RELATED TO THE USE OF THE DA VINCI SINGLE PORT (SP) SYSTEM. THE SURGEON WAS BEING PROCTORED THIS PROCEDURE. THE SURGEON REPORTED THAT THE PATIENT RECEIVED NORMAL THROMBOSIS PROPHYLAXIS WITH TIGHT SOCKS AND LOW MOLECULAR HEPARIN POSTOPERATIVELY FROM OR-DAY AND ONWARDS (HOSPITAL STANDARD). THE PATIENT EXPERIENCED A THROMBOEMBOLIC PULMONAL EMBOLISM CENTRALLY WITH PAIN AND DIFFICULTIES TO BREATH WITHOUT A FULMINANT EVENT TWO DAYS AFTER SURGERY. THE PATIENT EXPERIENCED DIFFICULTIES TO RECOVER APPROPRIATELY AFTER SURGERY AND DID NOT FEEL WELL. THE EMBOLISM WAS CONFIRMED WITH A CT-SCAN OF THE THORAX AND ELEVATED D-DIMER SCORES. THE PATIENT RECEIVED CONSERVATIVE TREATMENT WITH HEPARIN ON A THERAPEUTIC LEVEL. THE PATIENT DEVELOPED A RETRO-VESICAL HEMATOMA AND INSUFFICIENCY OF THE ANASTOMOSIS WITH SEVERAL TRANSFUSIONS. THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT (ICU) WITH A PROLONGED HOSPITAL STAY; NO ADDITIONAL SURGERIES WERE PERFORMED. THE PATIENT WAS DISCHARGED WITHOUT SYMPTOMS (B)(6) 2024. DURING THE PROCEDURE, THE PATIENT WAS IN A \"NO TRENDELENBURG POSITION.\" THERE WERE NO MALFUNCTIONS OF THE SP SYSTEM AND NO SIGNS OF A GAS OR AIR EMBOLISM DURING THE PROCEDURE." } ], "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": "" } ] }