{ "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": "2955842-2026-05076", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260226", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20260130", "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": "JA", "manufacturer_contact_area_code": "", "date_added": "20260226", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250605", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "522166", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260226", "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": "K12250605 0152", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260220", "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)270630(10)K12250605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/05/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260604", "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": "20260226", "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": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260528", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24458524", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20260202", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "403361334", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: G3, G6, H2, H6, AND H11. CORRECTED DATA CAN BE FOUND IN THE H6 FIELDS (I.E. ANNEX C AND D CODES). ADDITIONAL INFORMATION: FURTHER INVESTIGATION IDENTIFIED OVER-MOLD DAMAGE AND THE LOSS OF MATERIAL FRAGMENTS DURING A PULMONARY SEGMENTECTOMY PROCEDURE. THERE WERE NO SIGNS OF ARCING." }, { "mdr_text_key": "403361335", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "394156526", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A WHITE FIBER-LIKE MATERIAL CAME OUT OF THE TIP OF THE SYNCHROSEAL INSTRUMENT. ALSO, FOREIGN MATERIAL-LIKE DEBRIS CAME OUT OF THE PATIENT'S BODY. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ABNORMALITIES WERE FOUND. DURING SURGERY, A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT; AN ASSISTANT PROMPTLY RETRIEVED IT. THE CAUSE OF THE BREAKAGE IS UNKNOWN, ALTHOUGH NO HARD OBJECTS WERE GRASPED AND NO INSTRUMENT COLLISIONS WERE OBSERVED, EXCEPT AT THE MOMENT WHEN THE FRAGMENT FELL INSIDE THE PATIENT DUE TO A TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY TWO HOURS BEFORE THE INCIDENT, WITH NO NOTED FUNCTIONAL ISSUES DURING SURGERY, AND NO RESISTANCE OR DAMAGE OBSERVED DURING REMOVAL. ALL FRAGMENTS WERE CONFIRMED RETRIEVED, NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED FOR REMOVAL, AND POST-OPERATIVE IMAGING CONFIRMED ABSENCE OF RETAINED FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY, NO INJURY OCCURRED TO THE PATIENT, AND NO POST-SURGICAL COMPLICATIONS HAVE BEEN REPORTED." }, { "mdr_text_key": "394156527", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT WAS RETURNED FOR FAILURE ANALYSIS EVALUATION. A VISUAL INSPECTION FOUND THE CUT ELECTRODE DAMAGED ON THE JAWS. THERE WAS MATERIAL FOUND MISSING. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED ENGAGEMENT AND RECOGNITION TESTS. THE INSTRUMENT'S SEAL AND SYNC FUNCTIONS WERE TESTED ON THE SYSTEM, AND BOTH TESTS PASSED. THERE WERE NO SIGNS OR ARCING. A REVIEW OF IMAGES PROVIDED BY THE CUSTOMER WAS PERFORMED. THE IMAGES WERE ZOOMED OUT. IN ONE IMAGE, IT LOOKED LIKE THERE COULD BE A TORN INSTRUMENT JAW COVER. IN ANOTHER IMAGE, A FRAGMENT IS VISIBLE BUT IS TOO BLURRY TO CLEARLY TELL WHAT IT WAS EXACTLY." } ], "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": "05/28/2026" } ] }