{ "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": "2955842-2026-22902", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260428", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20260323", "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": "EZ", "manufacturer_contact_area_code": "", "date_added": "20260428", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250731", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1082256", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260428", "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": "480440-07", "catalog_number": "480440", "lot_number": "K10250731 0293", "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)270731(10)K10250731", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/29/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260720", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260428", "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" ] } ], "distributor_city": "", "date_report": "20260522", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25020990", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20260331", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "403062606", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT TO PERFORM FAILURE ANALYSIS. A VISUAL INSPECTION REVEALED THAT THE CUT ELECTRODE WAS DISLODGED FROM ITS ORIGINAL POSITION AND WAS HANGING OUTSIDE THE JAWS. THE CUT ELECTRODE DISLODGED, AND THERE MAY BE MISSING PIECES; HOWEVER, THE SIZE OF THE MISSING PIECES CANNOT BE CONFIRMED, INDICATING THAT A FRAGMENT MAY HAVE DETACHED FROM THE INSTRUMENT. ADDITIONALLY, VISUAL INSPECTION FOUND THE CUT ELECTRODE THERMALLY DAMAGED ON THE JAWS. THE INSTRUMENT WAS FOUND TO HAVE THE WASHER DISLODGED FROM ITS ORIGINAL POSITION AND WAS STILL ATTACHED TO THE INSTRUMENT. THE JAW COVER WAS MOVED TO VERIFY THAT THE WASHER WAS STILL ATTACHED TO THE INSTRUMENT AND APPEARED TO REMAIN ATTACHED TO THE PIVOT PIN. ADDITIONAL INFORMATION: ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THERE WAS NO REPORTED DRAMATIC BLEEDING AS THE BLEEDING WAS UNDER CONTROL. THE BLOOD LOSS DID NOT OCCUR DUE TO AN ISI PRODUCT, OR ANY ANATOMICAL FACTORS. NO FRAGMENT WAS REPORTED TO HAVE BEEN LEFT IN THE PATIENT. THE JAW COVER WAS NOT TORN OR DAMAGED, THEREFORE NO ARCHING WAS OBSERVED. IT IS UNKNOWN IF THE JAWS ENCOUNTERED A CLIP, SUTURE, STAPLE OR ANOTHER METAL OBJECT WHEN THE REPORTED ISSUE WAS NOTED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO OBVIOUS DAMAGE NOTED. THE PATIENT'S CURRENT STATUS WAS NOT PROVIDED BY THE REPORTER, AND NO IMAGES OR VIDEOS OF THIS EVENT WERE AVAILABLE FOR REVIEW." }, { "mdr_text_key": "403062607", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "399780303", "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. THE SYNCHROSEAL INSTRUMENT LOGS SHOW THAT THE INSTRUMENT WAS INSTALLED 13 TIMES. THE E-100 GENERATOR LOGS SHOW THAT THE FIRST INSTRUMENT HAD 2 SEAL EVENTS WITH NO ERRORS AND 711 TRANSECT EVENTS WITH 4 SEAL ELECTRODES SHORTED ERRORS, 2 CUT ELECTRODES SHORTED ERRORS, AND 1 ¿BLANK¿ ERROR, INDICATING THAT 7 TRANSECT EVENTS LIKELY DID NOT FULLY GO THROUGH. THE LOGS SHOW THOSE CUT AND SEAL ELECTRODES SHORTED ERRORS AT THE SAME TIMESTAMPS AS ONE OF THOSE ERRORS SEEN IN E-100 GENERATOR LOGS. THE E-100 RECOVERABLE ERROR SEEN IN THE LOGS IS AT THE SAME TIME STAMP AS THAT OF THE ¿BLANK¿ ERROR. THE INSTRUMENT WAS USED FOR ABOUT 3 HOURS 47 MINUTES." }, { "mdr_text_key": "399780304", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT COMPLETELY DISINTEGRATED INTRAOPERATIVELY. THERE WAS A TOTAL OF 200 ML BLOOD LOSS. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW INSTRUMENT. THE FOLLOWING INFORMATION IS UNKNOWN: DETAILS REGARDING THE DISINTEGRATION OF THE INSTRUMENT, THE CAUSE AND SOURCE OF THE BLEEDING, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/22/2026" } ] }