{ "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": "2955842-2023-21297", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20231218", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20231122", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20231219", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230720", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "78869", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231218", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480440-06", "catalog_number": "480440", "lot_number": "L12230720 0117", "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(17)250731(10)L12230720", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/12/2023;03/22/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20231218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "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": "20231122", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18347022", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20231122", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Notification" ], "manufacturer_g1_zip_code": "", "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": "340146379", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "340146380", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. FAILURE ANALYSIS DID NOT REPLICATE NOR CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT MOVED INTUITIVELY AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS WHEN PLACED ON THE SYSTEM ARM. THE WHITE LED LIGHT ILLUMINATED FROM THE GENERATOR INDICATING THE INSTRUMENT WAS RECOGNIZED FOR ENERGY DELIVERY. ALL PROPER AUDIBLE TONES OCCURRED WHEN PEDALS WERE ACTIVATED FOR CUT ELECTRODE/SEALING. ALL CERAMIC DOTS WERE PRESENT. IN ADDITION, A CUT ELECTRODE WAS FOUND THERMALLY DAMAGED. MELTED CHARS MARKS WERE OBSERVED ALONG THE SILICON OVERMOLD/BLADE EDGE OF THE ELECTRODE." }, { "mdr_text_key": "338995429", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED 12-DEC-2023. SURGEON STATED THE SEALING CYCLE WAS COMPLETED DURING THE EVENT AND NO ERROR MESSAGES OCCURRED." }, { "mdr_text_key": "338995430", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "330738610", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED FOR RETURN OF THE SYNCHROSEAL INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE INSTRUMENT. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. THE SYNCHROSEAL LOGS FOR THIS EVENT WERE REVIEWED; THE LOGS COULD NOT DETERMINE THE CAUSE OF THE CUSTOMER REPORTED EVENT. THE SYSTEM LOGS SHOWED NO RELEVANT ERRORS TO THE REPORTED EVENT." }, { "mdr_text_key": "330738611", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, BLEEDING OCCURRED WHILE THE SURGEON WAS USING THE 8MM SYNCHROSEAL INSTRUMENT. THE SURGEON REPORTED THAT THE EVENT OCCURRED DURING TRANSECTION OF A PULMONARY ARTERIAL BRANCH AND SEALING OF THE VESSEL WAS NOT ACHIEVED WITH THE SYNCHROSEAL INSTRUMENT. THERE WAS AN UNKNOWN AMOUNT OF BLEEDING THAT HAD OCCURRED. THE ARTERY WAS CLAMPED WITH A FORCEPS AND THE PROCEDURE WAS CONVERTED TO OPEN SURGERY TO REPAIR THE VESSEL. IT IS UNKNOWN HOW THE ARTERY WAS REPAIRED. THIS EVENT CAUSED A THIRTY-MINUTE PROCEDURE DELAY. IT WAS CONFIRMED THERE WAS NO BLOOD TRANSFUSION ADMINISTERED AS A RESULT OF THE BLEEDING. IN ADDITION, THE PATIENT DID NOT EXPERIENCE ANY POSTOPERATIVE COMPLICATION. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY NUMBER THREE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/27/2023;04/11/2024" } ] }