{ "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": "2955842-2023-10740", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20230217", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230102", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20230217", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220325", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "656628", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230217", "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": "L91220325", "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)240331(10)L91220325", "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": "04/06/2023;05/22/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20230217", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230124", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16400543", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230124", "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": "336884773", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336884774", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADVANCED FAILURE ANALYSIS WAS COMPLETED. THE INITIAL FAILURE ANALYSIS FINDING WAS CONFIRMED. THE E-100 GENERATOR LOGS SHOWED 21 INSTANCES OF CUT ELECTRODES SHORTED AND 17 INSTANCES OF SEAL ELECTRODES SHORTED ERRORS WHICH COULD LIKELY BE RELATED TO THE THERMAL DAMAGE OBSERVED. ADDITIONAL KEYENCE OPTICAL MICROSCOPE IMAGE REVIEW DID NOT SHOW ANY SIGNS OF THE HEAT STAKED PLASTIC BEING DEFORMED/MELTED." }, { "mdr_text_key": "335421649", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335421650", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION FOUND THE PRIMARY FAILURE OF BROKEN CUT ELECTRODE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN CUT ELECTRODE. THE SILICONE OVERMOLD PART OF THE CUT ELECTRODE WAS FOUND TO HAVE A MISSING PIECE AND WAS OBSERVED TO BE DISLODGED. THE BROKEN PIECE, MEASURING APPROXIMATELY 0.059\" X 0.081\" IN SIZE, WAS NOT RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION, ENGAGEMENT, AND SELF-CHECK TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. UPON VISUAL INSPECTION, ALL 9 JAW CERAMIC DOTS WERE PRESENT AT THE TIPS. THE INSTRUMENT WAS CONNECTED TO THE E-100 GENERATOR WITHOUT ANY ISSUES. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE CUT ELECTRODE LOCATED ON THE BOTTOM JAW OF THE GRIP SET. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE WERE ALSO IDENTIFIED. THE INSTRUMENT WAS FOUND TO HAVE A TORN JAW COVER AT THE PROXIMAL END. THE TEARS MEASURED APPROXIMATELY 0.041\" - 0.360\" IN LENGTH. THERE WERE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS WERE 0.103¿ 172 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS." }, { "mdr_text_key": "309873982", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION IS BEING CONDUCTED. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ISI HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SYNCHROSEAL BROKE AND UNINTENDED FRAGMENTS FELL INSIDE THE PATIENT DURING A DA VINCI-ASSISTED PROCEDURE. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR." }, { "mdr_text_key": "309874023", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, SMALL WHITE STRIPS IN THE CENTER OF THE SYNCHROSEAL JAWS BROKE OFF AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS WERE RETRIEVED BY THE SURGEON USING ANOTHER FORCEPS. THE SURGEON SAID THAT HE HAD RETRIEVED ALL THE FRAGMENTS. THE FRAGMENTS WERE WHITE IN COLOR AND WERE EASILY SPOTTED. THE FRAGMENTS WERE REMOVED DURING THE SAME PROCEDURE; THERE WAS NO NEED TO RE-INTERVENE. IMAGING EXAMINATIONS WERE PERFORMED POST-SURGERY BUT NOT TO SEARCH FOR THESE FRAGMENTS. IT IS UNKNOWN WHAT CAUSED THE FRAGMENTS TO FALL OFF. THE PROBLEM OCCURRED NEAR THE END OF THE SURGERY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE; THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR OTHER HARD MATERIALS. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO THE RETENTION OF A FOREIGN BODY." } ], "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": "05/04/2023;06/21/2023" } ] }