{ "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": "2955842-2023-19723", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20231106", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230927", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20231106", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230608", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1297351", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231106", "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": "L15230608 0358", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20231101", "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)250630(10)L15230608", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/01/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250819", "health_professional": "Y", "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": "20231106", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20231009", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18078835", "removal_correction_number": "N/A", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "338360258", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED PROPERLY. THE INSTRUMENT SYNCED AND SEALED TWICE WITH NO ISSUES. THE INSTRUMENT PASSED AN ELECTRIC CONTINUITY, CERAMIC DOT, AND JAW GAP VERIFICATION TESTS." }, { "mdr_text_key": "338360259", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "327484447", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY PROCEDURE, AN ERROR DISPLAYED STATING THERE WAS AN ISSUE WITH THE JAW OF THE SYNCHROSEAL INSTRUMENT. A WHITE FRAGMENT FELL INSIDE THE PATIENT'S CAVITY AND WAS RETRIEVED DURING THE SAME PROCEDURE. IT WAS UNKNOWN IF THE FRAGMENT CAME FROM THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE CUSTOMER CONFIRMED THAT THERE WERE NO ISSUES WITH INITIAL CLAMPING AND UNCLAMPING OR ENERGY DELIVERY DURING INTRAOPERATIVE USE. WHEN THE CUSTOMER USED THE INSTRUMENT FOR OVER 10 MINUTES TO GRASP UNSPECIFIED TISSUE, THE FRAGMENT FELL INSIDE THE PATIENT'S CAVITY. THE FRAGMENT WAS RETRIEVED DURING SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. POST-OPERATIVE TESTS AND ADDITIONAL SURGICAL PROCEDURE WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT AND THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). THE INSTRUMENT'S WRIST WAS STRAIGHTENED PRIOR TO REMOVAL AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. BOTH INSTRUMENT AND CANNULA HAD NO OTHER DAMAGE AFTER THE EVENT OCCURRED. THE PATIENT HAD NO INJURY OR HARM AND HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." }, { "mdr_text_key": "327484448", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SYNCHROSEAL INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A REVIEW OF THE SYSTEM LOGS REVEALS NO ERRORS OCCURRED IN RELATION TO THE CUSTOMER REPORTED ISSUE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE." } ], "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": "11/29/2023" } ] }