{ "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": "2955842-2024-17369", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240729", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20240703", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20240729", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241105", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "933283", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240729", "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": "480440-05", "catalog_number": "480440", "lot_number": "L12240125 0174", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(10)L12240125", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Difficult to Open or Close", "Difficult to Open or Close" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/08/2024", "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": "20240729", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240704", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19855950", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240704", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "359216243", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "359216244", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SYNCHROSEAL INSTRUMENT AND FAILURE ANALYSIS AND DID NOT CONFIRM OR REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP TIPS OPENED AND CLOSED PROPERLY. ADDITIONALLY, VISUAL INSPECTION FOUND THE PART TO BE DAMAGED, AS THE INSTRUMENT WAS RETURNED WITH THE POWER CORD CUT OFF." }, { "mdr_text_key": "348007452", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE THE SYNCHROSEAL INSTRUMENT THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND REVEALED A POSSIBLE RELATED SYSTEM ERROR: RADIO FREQUENCY IDENTIFICATION (RFID) ERROR ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3, FAILED TO SETUP COMMUNICATION TO RFID TAG - POLL SINGLE COMMAND FAILURE (CANNOT FIND A RFID CARD/TAG). ADVANCE ENERGY LOG REVIEW DID NOT SHOW ANY EVENTS FROM THE FIRST SYNCHROSEAL INSTRUMENT (LOT NUMBER: L12240125-0174). THE SECOND SYNCHROSEAL INSTRUMENT (LOT NUMBER: L12240125-0193) HAS 32 SEAL EVENTS WITH NO ERRORS AND 53 TRANSECT EVENTS WITH 5 HIGH INITIAL STARTING IMPEDANCE ERRORS. THE INSTRUMENT WAS USED FOR ABOUT 37 MINUTES. THE LOGS DON¿T SHOW ANY SYNCHROSEAL RELATED ERRORS. TISSUE STICKING COULD BE DUE TO EXCESSIVE BIO-DEBRIS BETWEEN JAWS OR DUE TO TRYING TO SEAL TOO THICK OF TISSUE." }, { "mdr_text_key": "348007453", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE JAWS OF THE SYNCHROSEAL INSTRUMENT, WOULD NOT OPEN AND BECAME STUCK WHILE RETRACTING FATTY TISSUE. THE SYNCHROSEAL INSTRUMENT HAD BEEN IN USE FOR HALF OF THE PROCEDURE, WHEN A RECOVERABLE FAULT OCCURRED, AND AN ERROR MESSAGE WAS OBSERVED. THE EMERGENCY STOP BUTTON WAS PRESSED, AND THE INSTRUMENT RELEASE KEY WAS USED; HOWEVER, THE INSTRUMENT JAWS COULD NOT BE OPENED. THE SURGEON DECIDED TO CUT AWAY THE FATTY TISSUE, TO FREE THE SYNCHROSEAL INSTRUMENT. THERE WAS NO BLEEDING THAT OCCURRED WITH THE UNPLANNED REMOVAL OF FATTY TISSUE. A BACKUP INSTRUMENT WAS USED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY; THERE WERE NO POST-OPERATIVE COMPLICATIONS." } ], "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": "12/02/2024" } ] }