{ "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": "2955842-2024-20193", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20241008", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20240626", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20241008", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "685780", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241008", "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": "480440-03", "catalog_number": "480440", "lot_number": "L10240109", "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": "", "udi_public": "", "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": "11/25/2024;12/30/2024;02/12/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20241008", "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": "20240910", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20402245", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240910", "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": "365761508", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON (B)(6) 2025 FURTHER FAILURE ANALYSIS INVESTIGATION WAS PERFORMED ON THE SYNCHROSEAL INSTRUMENT. DUE TO THE EXTENT OF THE DAMAGE OBSERVED ON THE JAW COVER, IT IS LIKELY THAT THE JAW COVER (SOFT SILICONE MATERIAL) WAS STRETCHED AND PULLED OVER THE PIVOT PIN WASHER DURING AN INTRAOPERATIVE COLLISION. ADDITIONALLY, WITH THE JAW COVER TORN, IT IS SIGNIFICANTLY EASIER TO DEFORM AND STRETCH OVER THE PIVOT PIN WASHER. IT IS UNLIKELY THAT THE WASHER GOT INSTALLED UNDER THE JAW COVER, BECAUSE THE INSTRUMENT GOES THROUGH SEVERAL LEVELS OF DOWNSTREAM VISUAL INSPECTION THAT IT WOULD NEED TO PASS." }, { "mdr_text_key": "362922727", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 30-DEC-2024, FURTHER FAILURE ANALYSIS WAS PERFORMED, AND THE INITIAL FINDINGS WERE CONFIRMED. THE CUT ELECTRODE WAS OBSERVED TO BE TORN OFF AT THE DISTAL END, AND THERE WAS MATERIAL MISSING. THE CUT ELECTRODE METAL SURFACE DID NOT EXHIBIT ANY WAVINESS THAT IS TYPICALLY DUE TO THERMAL DAMAGE. THE E100 GENERATOR LOGS FOR THIS SYNCHROSEAL INSTRUMENT SHOW THAT THE INSTRUMENT WAS USED FOR OVER 4 HOURS, AND HAD 4 COAG EVENTS, 98 SEAL EVENTS (NO ERRORS) AND 735 TRANSECT EVENTS (WITH 18 HIGH INITIAL STARTING IMPEDANCE ERRORS). ADDITIONALLY, THE SYNCHROSEAL INSTRUMENT DID NOT HAVE ANY WASHER MISSING. THE JAW COVER WAS REMOVED, AND THE WASHER WAS FOUND TO BE UNDER THE JAW COVER, WHICH COULD LIKELY HAPPEN DUE TO A WORKMANSHIP ISSUE DURING MANUFACTURING, WHERE THE JAW COVER WAS INSTALLED AFTER INSTALLING THE WASHER." }, { "mdr_text_key": "353709553", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE ONLY TWO THINGS THEY COULD THINK OF THAT COULD POTENTIALLY FRAGMENT FROM SYNCHROSEAL AND LOOKED LIKE THIS ARE THE PLASTIC HEAT STAKE AND A SMALL PART FROM THE CUT ELECTRODE (SINCE THAT'S WHITE IN COLOR, KIND OF LIKE THIS FRAGMENT)." }, { "mdr_text_key": "353709554", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, DISLODGED TIPS AND WHITE LOOSE PART ON SYNCHOSEAL/EAGLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY." }, { "mdr_text_key": "359745501", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE CUT ELECTRODE BROKEN. BOTH SIDES OF THE CUT ELECTRODE OVERMOLD WAS TORN AT THE DISTAL TIP. THERE WAS MATERIAL MISSING. THE BROKE PIECE WAS NOT RETURNED WITH THE INSTRUMENT. THE CUT ELECTRODE WAS EXPOSED AT THE DISTAL TIP. THERE WAS DAMAGE TO THE ADJACENT PARTS. THE JAW COVER AND WASHER WAS DAMAGED. THE INSTRUMENT WAS ALSO FOUND TO HAVE THE WASHER MISSING FROM ITS ORIGINAL POSITION. THE INSTRUMENT WAS COMPARED TO AN IN-HOUSE GOLDEN SYNCHROSEAL INSTRUMENT, AND THE WASHER WAS FOUND TO BE MISSING. THE MISSING PIECE WAS NOT RETURNED WITH THE INSTRUMENT. THE JAW COVER WAS FOUND TO HAVE TEARING. THE TEARS MEASURED FROM 0.024¿ TO 0.544¿ IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. MATERIAL WAS FOUND TO BE MISSING." }, { "mdr_text_key": "359745502", "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": "12/19/2024;01/23/2025;03/12/2025" } ] }