{ "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": "2955842-2024-18936", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240905", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20240809", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20240905", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240307", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2268131", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240905", "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": "K12240307 0246", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240828", "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)260331(10)K12240307", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Break" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/10/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250814", "health_professional": "N", "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": "20240905", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240809", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20151396", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20240809", "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": "352642906", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INITIAL FINDINGS WERE CONFIRMED. THE HEAT STAKED PLASTIC WAS FOUND MISSING FROM THE AREA WHERE THE CUT ELECTRODE AND THE JAW ARE HELD TOGETHER. A REVIEW OF E100 GENERATOR LOGS SHOWED NO SHORTING EVENTS WHICH COULD HAVE LED TO A LOCALIZED INCREASE IN TEMPERATURE POTENTIALLY CAUSING THE HEAT STAKE TO MELT/DEFORM AND EVENTUALLY BREAK. NO OTHER USER RELATED DAMAGE WAS SEEN AT THE DISTAL END THAT COULD OTHERWISE HAVE CONTRIBUTED TO THE FAILURE. THE FRAGMENT MENTIONED IN THE COMPLAINT WAS RETURNED AND COMPOSITIONAL INFORMATION AND VISUAL INSPECTION SHOWED A CLOSE MATCH WITH THE OVER MOLDED CUT ELECTRODE OF SYNCHROSEAL INSTRUMENT, INDICATING THAT IT WAS THE HEAT STAKED PORTION OF THE CUT ELECTRODE THAT BROKE OFF DURING THE PROCEDURE." }, { "mdr_text_key": "352642907", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "351061221", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SYNCHROSEAL INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF GRIP TIP OTHER TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION FOUND THE HEAT SINK MISSING FROM THE UPPER JAW. THE INSTRUMENT WAS COMPARED TO A IN HOUSE INSTRUMENT AND FOUND THE GREY HEAT SINK WAS MISSING COMPARED THE OTHER. THE PIECE MEASURES APPROXIMATELY 0.070'' IN DIAMETER. THE PIECE WAS NOT RETURNED WITH THE INSTRUMENT. THE COMPONENTS ADJACENT TO THE MISSING HEAT SINK DID NOT SHOW ANY DAMAGE. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED, AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IT COULD LIKELY BE A PIECE OF THE JAW COVER WHICH COULD GET TORN AND FALL INTO THE PATIENT." }, { "mdr_text_key": "351061223", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A FRAGMENT THAT WAS BELIEVED TO BE FROM A DAVINCI SYNCHROSEAL INSTRUMENT WAS FOUND INSIDE OF THE PATIENT¿S ANATOMY AND WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT APPEARED TO BE PART OF THE SYNCHROSEAL INSTRUMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS REMOVED BY USING FORCEPS FOR ENDOSCOPIC SURGERY. A THORACOSCOPIC OPERATION WAS REQUIRED TO REMOVE THE FRAGMENT. AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS 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": "09/20/2024" } ] }