{ "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": "2955842-2025-25557", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250617", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20250416", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20250617", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241017", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1156020", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250617", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "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": "480440-06", "catalog_number": "480440", "lot_number": "K10241017 0244", "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": "10886874117306", "udi_public": "(01)10886874117306(17)261031(10)K10241017", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Seal", "Failure to Seal" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "health_professional": "", "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": "20250617", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20250521", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22229551", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20250521", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Notification", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "372601955", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. AN ADVANCE ENERGY LOG REVIEW OF THE SYNCHROSEAL INSTRUMENT, SHOWS 1 COAG EVENT AND 63 SEAL EVENTS WITH NO ERRORS. THERE WAS 116 TRANSECT EVENTS WITH 1 HIGH INITIAL STARTING IMPEDANCE WERE NOTED. THE MSC LOGS ALSO SHOW AN E-100 ERROR WITH HIGH INITIAL STARTING IMPEDANCE AT THE SAME TIME AS THE ONE PREVIOUSLY MENTIONED. IT IS LIKELY THAT THE USER TRIED TO TRANSECT THICKER THAN SPECIFIED TISSUE." }, { "mdr_text_key": "372601956", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH NEOBLADDER PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING THAT REQUIRED AN ADDITIONAL PROCEDURE. THE EXACT SEQUENCE OF EVENTS LEADING TO THE BLEEDING REMAINS UNCLEAR, AND IT IS ALSO UNKNOWN WHETHER THE PATIENT HAD ANY UNDERLYING COAGULOPATHY OR WAS TAKING MEDICATIONS THAT MAY HAVE CONTRIBUTED. IMAGING REVEALED BLEEDING ORIGINATING FROM THE SITE WHERE THE SYNCHROSEAL INSTRUMENT HAD BEEN SUCCESSFULLY USED ON A VESSEL LESS THAN 5 MM IN DIAMETER. THE DEVICE WAS OPERATED IN SYNCH MODE, WITH A CONTINUOUS TONE DURING PEDAL ACTIVATION AND THREE ASCENDING AUDIBLE TONES CONFIRMING COMPLETION OF THE SEAL. ADDITIONALLY, THE SURGEON REPORTED SEALING BOTH SIDES OF THE VESSEL AFTER COMPLETING THE TRANSECTION. TO ADDRESS THE BLEEDING, A SUBSEQUENT PROCEDURE WAS PERFORMED, DURING WHICH HEMOSTASIS WAS ACHIEVED USING A HEMOSTATIC AGENT AND SUTURING. ALTHOUGH THE EXACT VOLUME OF BLOOD LOSS WAS NOT PROVIDED, THE PATIENT RECEIVED AN UNSPECIFIED NUMBER OF BLOOD TRANSFUSIONS. THE PATIENT HAS SINCE RECOVERED, AND THE SURGEON DOES NOT ANTICIPATE ANY LONG-TERM COMPLICATIONS AS A RESULT OF THE EVENT." } ], "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": "" } ] }