{ "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": "2955842-2025-15514", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250417", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20250327", "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": "408", "date_added": "20250417", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240718", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "754577", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250417", "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": "K11240718 0321", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250414", "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)260731(10)K11240718", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/13/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250728", "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": "20250417", "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", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250327", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21859783", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250327", "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": "368414584", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT WAS RECEIVED, AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE A DISLODGED AND MISSING HEAT STAKED PLASTIC THAT CONNECTS THE CUT ELECTRODE WITH THE JAW. THE PLASTIC WAS NOT IN ITS ORIGINAL LOCATION AND WAS MISSING. THE CUT ELECTRODE WAS STILL IN PLACE. THE INSTRUMENT PASSED THE CONTINUITY TEST. A REVIEW OF THE PROVIDED IMAGES SHOWED THAT THE LITTLE PIECE COULD LIKELY BE THE HEAT STAKED PLASTIC PART THAT HOLDS THE CUT ELECTRODE AND THE JAW TOGETHER. LOOKING AT THE CIRCULAR SHAPE, IT MOST LIKELY WAS THE HEAT STAKED PLASTIC." }, { "mdr_text_key": "368414585", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL TUMOR RESECTION PROCEDURE, FRAGMENTS FROM THE SYNCHROSEAL INSTRUMENT FELL OUT INTO THE PATIENT. THE MEDICAL DIRECTOR AND PRIMARY SURGEON FOR THE CASE STATED THAT IT WAS UNCLEAR WHEN THE DEVICE FRAGMENT FELL INTO THE PATIENT DURING THE PROCEDURE. THE SURGEON STATED THAT THE FRAGMENT WAS RETRIEVED BY REMOVING THE SYNCHROSEAL, UNDOCKING THE SYSTEM, AND USING VATS FORCEPS TO EXTRACT THE PART; THIS WAS CONFIRMED VISUALLY. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND AN X-RAY EXAMINATION WAS PERFORMED POST-OPERATIVELY TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP VESSEL SEALER EXTEND WITH NO INJURY TO THE PATIENT." }, { "mdr_text_key": "371285490", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN ADDITIONAL EVALUATION OF THE SYNCHROSEAL INSTRUMENT HAS BEEN PERFORMED. THE INITIAL FINDINGS WERE CONFIRMED. THE INSTRUMENT WAS FOUND TO HAVE A MISSING HEAT STAKED PLASTIC, BUT THE CUT ELECTRODE WAS FOUND TO BE INTACT AND NOT DISLODGED. A REVIEW OF THE PROVIDED VIDEO SHOWS THE HEAT STAKED PLASTIC FALLS INTO THE PATIENT BUT THE INSTRUMENT CONTINUES TO FUNCTION NORMALLY. THERE WERE ALSO NO WASHERS THAT FELL INTO THE PATIENT." }, { "mdr_text_key": "371285491", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "05/29/2025" } ] }