{ "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": "2955842-2023-12216", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230426", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230329", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20230426", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220825", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1591554", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230426", "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": "L11220825 0115", "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)240831(10)L11220825", "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": "07/18/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20230426", "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": "20230330", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16820536", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230330", "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": "336888536", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336888537", "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 FOUND TO HAVE DAMAGED INSULATION OF THE MAIN TUBE AT THE DISTAL END. A PIECE APPROXIMATELY 0.169\" X 0.11\" WAS NOT RETURNED WITH THE INSTRUMENT. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE THAT ARE NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT WERE IDENTIFIED. THE SYNCHROSEAL INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE TO THE WHITE COMPONENT OF THE CUT ELECTRODE AT THE DISTAL END. THE INSTRUMENT WAS FOUND TO HAVE FAILED THE ELECTRICAL CONTINUITY TEST. BOTH INSTRUMENT JAWS WOULD PASS FOR ELECTRICAL CONTINUITY FOR BOTH ENDS AT THE INTEGRATED CONNECTOR. THE CUT ELECTRODE CONNECTION WOULD ALSO PASS FOR THE CONNECTIONS FOR BOTH JAWS AT THE INTEGRATED CONNECTOR. NO OBVIOUS SIGNS OF DAMAGE WERE FOUND. IT WAS UNABLE TO INSPECT THE PROXIMAL END DUE TO THE HOUSING BEING STUCK. A REVIEW OF THE LOGS SHOWED NO ERRORS. ADVANCE FAILURE ANALYSIS WAS PERFORMED AND THE INITIAL FAILURE NALYSIS RESULTS WERE CONFIRMED. THE CONTINUITY TEST FAILURE WAS INVESTIGATED USING X-RAY ANALYSIS. AN INSPECTION OF THE PROXIMAL END OF THE INSTRUMENT SHOWED THERMAL DAMAGE TO THE WIRES IN CERTAIN AREAS (WIRES FUSED TOGETHER, AS WELL AS THE INSULATION THINNED OUT AT PLACES). THE INSTRUMENT WAS SUCCESSFULLY USED FOR ABOUT 2 HOURS." }, { "mdr_text_key": "314072949", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A FRAGMENT FELL INTO A PATIENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SYNCROSEAL INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: REGARDING THE PICTURE, IT APPEARS THAT A PIECE OF THE GRAY EPOXY INSULATION HAS DETACHED FROM THE MAIN TUBE. INTRAOPERATIVE COLLISIONS IS A POTENTIAL CAUSE OF THIS DAMAGE. THIS IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FROM A SYNCHOSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE." }, { "mdr_text_key": "314072950", "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 PIECE OF THE SHAFT PROTECTIVE COVERING ON THE SYNCROSEAL INSTRUMENT BROKE AND FELL INTO THE PATIENT. THEY WERE ABLE TO REMOVE THE PIECE DURING THE SAME SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE INSTRUMENT WAS INSPECTED BEFORE THE PROCEDURE WITH NO DAMAGE NOTED. IT WAS POSSIBLE THAT THE INSTRUMENT COLLIDED WITH ANOTHER ONE. THE ISSUE OCCURRED AROUND 2 HOURS INTO THE PROCEDURE. THE ASSISTANT USED THE GRASPER TO REMOVE THE FRAGMENT AND THE WRIST WAS STRAIGHTENED TO REMOVE. THE ASSISTANT PORT THAT WE HAD ALREADY WAS USED, AND THEY TOOK THE PART OUT WITH A LAPAROSCOPIC INSTRUMENT, THE SURGERY WAS NOT CONVERTED TO LAPAROSCOPY." } ], "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": "08/13/2023" } ] }