{ "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": "2955842-2025-28914", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250708", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20250610", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250708", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250123", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1424199", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250708", "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": "K13250123 0122", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250630", "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)K13250123", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Deliver Energy", "Failure to Deliver Energy" ], "reporter_state_code": "AR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/08/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250814", "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": "20250708", "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": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20250610", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22437193", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20250610", "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": "374824541", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "374824542", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: D4, H3, ANNEX CODES. ADDITIONAL INFORMATION: INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL WAS ANALYZED, AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT WAS RETURNED WITH THE POWER CORD CUT OFF. VISUAL INSPECTION DID NOT REVEAL ANY THERMAL DAMAGE OR SIGNS OF \"MELTING\". THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. NO ERRORS WERE FOUND IN THE LOGS. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE THE JAW COVER TORN. THE TEARS MEASURED ROUGHLY 0.0395\" X 0.0205\". VISUAL INSPECTION DISPLAYED NO SIGNS OF MISSING FRAGMENTS. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. THE JAWS DID NOT OPEN AND CLOSE PROPERLY AS THE COVER WAS EXTENDED TO THE BASE OF THE JAWS. THE INSTRUMENT WAS FOUND TO HAVE A BENT MAIN TUBE. THE BENDING DAMAGE IS LOCATED AT THE MIDPOINT AREA. THIS CAUSED THE JAWS NOT TO MOVE PROPERLY. COMPONENTS ADJACENT TO THIS BENT MAIN TUBE DID NOT SHOW DAMAGE. AN ADVANCE ENERGY LOG REVIEW OF THE TOOL TABLE, SHOWS THE SYNCHROSEAL INSTRUMENT WAS USED FOR APPROXIMATELY 25 MINUTES DURING THE PROCEDURE. THERE WERE NO ERRORS RELEVANT TO THIS INSTRUMENT IN THE LOGS. THE LOGS SHOW AN ERROR CODE, INDICATING THAT THE ERBE ENERGY ACTIVATION WAS HALTED BY AN 'INSTRUMENT OR INSTRUMENT CABLE CONNECTED TO THE UPPER BIPOLAR PORT ON THE ERBE WHILE SEALING WITH A VESSEL SEALER¿. THE ERROR IS NOT RELEVANT TO THE USE OF THE REPORTED SYNCHROSEAL INSTRUMENT, AS THE ERROR OCCURRED DURING THE USE OF A VESSEL SEALER EXTEND INSTRUMENT. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "374340556", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SYNCHROSEAL INSTRUMENT FOR FAILURE ANALYSIS. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE INSTRUMENT HAS NOT BEEN COMPLETED." }, { "mdr_text_key": "374340557", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE SYNCHROSEAL INSTRUMENT FAILED TO PROPERLY SEAL FROM THE BEGINNING OF THE PROCEDURE, RESULTING IN MINOR BLEEDING. DURING THE SEALING SEQUENCE, A CONTINUOUS SEALING TONE WAS HEARD WHILE THE PEDAL WAS PRESSED, FOLLOWED BY THREE FAST ASCENDING AUDIBLE TONES, INDICATING THAT THE SEALING OR SYNC MODE CYCLE HAD SUCCESSFULLY COMPLETED. THE TARGET TISSUE WAS NOT UNDER TENSION DURING THE SEALING AND CUTTING PROCESS, AND NO TISSUE WAS CUT THAT WAS NOT FULLY SEALED. DESPITE OBSERVING THE DESIRED TISSUE EFFECT ON THE FALLOPIAN TUBES AND OVARIES, THE SEALING CYCLE WAS NOTED TO BE PROLONGED, AND AN INCOMPLETE SEAL OCCURRED. LESS THAN 25 ML OF UNEXPECTED BLEEDING OCCURRED FROM A VESSEL THAT WAS NOT GREATER THAN 5 MM IN DIAMETER. THERE WAS NO EVIDENCE OF VESSEL CALCIFICATION, AND THE TISSUE HAD NOT BEEN EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. FURTHERMORE, THERE WAS NO ARCING OR ERRORS WHEN THE SYNCHROSEAL ISSUE OCCURRED, AND THE JAWS DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS WHEN THE REPORTED ISSUE WAS NOTED. A BLOOD TRANSFUSION WAS NOT REQUIRED, AND THE BLEEDING WAS RESOLVED USING A BACKUP SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY." } ], "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": "07/14/2025" } ] }