{ "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": "2955842-2024-21921", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20241115", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20241021", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "NL", "manufacturer_contact_area_code": "408", "date_added": "20241115", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "42388", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241115", "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": "K14240620 0046", "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": [ "Failure to Seal", "Failure to Seal" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/09/2024;02/14/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20241115", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "75 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20241021", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20696171", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20241021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Notification", "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": "365761914", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "365761915", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: D9, H2, H3, AND H6 DEVICE EVALUATION: INTUITIVE SURGICAL INC. (ISI) RECEIVED THE SYNCHROSEAL (LOT #K14240620-0046) INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION, SEAL AND ENGAGEMENT TESTS ON 3 OF 3 ATTEMPTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THERE WERE NO SEAL TEST FAILURES REPORTED IN THE LOGS DURING TESTING. THERE WAS NO PHYSICAL DAMAGE OBSERVED DURING TESTING." }, { "mdr_text_key": "356754710", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH EXTRAPERITONEAL LYMPHADENECTOMY PROCEDURE, TISSUE WAS INSUFFICIENTLY SEALED WITH A SYNCHROSEAL INSTRUMENT AND BLEEDING OCCURRED. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THE ISSUE OCCURRED DURING THE SEALING SEQUENCE. INSTEAD OF HEARING A CONTINUOUS TONE WHILE THE PEDAL WAS PRESSED, A SHORT TONE WAS HEARD. THE DESIRED TISSUE EFFECT COULD BE SEEN, BUT AT THE COMPLETION OF THE SEALING CYCLE; ONLY ONE TONE WAS HEARD INSTEAD OF THREE ASCENDING FAST AUDIBLE TONES. AN ERROR MESSAGE OF ¿TAKE THE RIGHT AMOUNT OF TISSUE¿ WAS OBSERVED. THE SURGEON BELIEVES THAT THE SYNCHROSEAL INSTRUMENT STOPPED SEALING TOO EARLY, CAUSING BLEEDING WHEN THE TISSUE WAS CUT. THE AMOUNT OF BLEEDING WAS NOT SPECIFIED BUT WAS REPORTED AS ¿NOT CRITICAL¿ AND WAS RESOLVED USING DIATHERMY; THE PATIENT DID NOT REQUIRE A TRANSFUSION OF BLOOD PRODUCTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED TO HELP TROUBLESHOOT THE ISSUE; THE ERROR LOGS WERE REVIEWED WITH NO ERRORS WERE IDENTIFIED. PER THE ADVICE FROM THE TSE, THE SYNCHROSEAL INSTRUMENT WAS REPLACED WITH A BACKUP INSTRUMENT; HOWEVER, THE ISSUE REMAINED THE SAME. THE SURGEON PROCEEDED TO COMPLETE THE PROCEDURE ROBOTICALLY, WITHOUT THE USE OF THE SYNCHROSEAL INSTRUMENT. THE NURSE ALSO REQUESTED AN ISI FIELD SERVICE ENGINEER TO INSPECT THE E-100 GENERATOR. ISI CONTACTED THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED." }, { "mdr_text_key": "356754711", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT AND WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED COMPLAINT. DUE TO STAFF REPORTING RECURRENT EVENTS OF THE SYNCHROSEAL INSTRUMENT INSUFFICIENTLY SEALING; THE E-100 GENERATOR WAS PREVENTATIVELY REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE E-100 GENERATOR INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS EVALUATION. ISI DID NOT RECEIVE THE SYNCHROSEAL INSTRUMENT (LOT NUMBER: K14240620-0046) THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. A LOG REVIEW OF THE E-100 GENERATOR LOGS REVEALED THE FOLLOWING: THE SYNCHROSEAL INSTRUMENT (LOT NUMBER: K14240620-0046) WAS USED FOR 4 COAG EVENTS WITH NO ERRORS, 8 SEAL EVENTS WITH 1 HIGH INITIAL STARTING IMPEDANCE ERROR AND 39 TRANSECT EVENTS WITH 3 HIGH INITIAL STARTING IMPEDANCE ERRORS. THE INSTRUMENT WAS USED FOR ABOUT 25 MINUTES. THE SYNCHROSEAL INSTRUMENT (LOT NUMBER: K14240620-0039) WAS USED FOR 10 COAG EVENTS, 10 SEAL EVENTS AND 52 TRANSECT EVENTS WITH NO ERRORS. THE INSTRUMENT WAS USED FOR ABOUT 22 MINUTES. THE HIGH INITIAL STARTING IMPEDANCE ERRORS COULD LIKELY BE RELATED TO THE COMPLAINT. REFER TO MEDWATCH REPORT (MDR) WITH MFR REPORT #2955842-2024-21922 FOR ADDITIONAL INFORMATION REGARDING THE 2ND SYNCHROSEAL INSTRUMENT. ." }, { "mdr_text_key": "360493863", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: INTUITIVE SURGICAL INC. (ISI) RECEIVED THE E-100 GENERATOR TO PERFORM FAILURE ANALYSIS AND DID NOT CONFIRM OR REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE UNIT WAS INSTALLED ONTO THE TEST SYSTEM AND MANUALLY POWER CYCLED 10 TIMES; THE E-100 GENERATOR POWERED ON WITH NO ISSUE EACH TIME. A VESSEL SEALER INSTRUMENT WAS INSTALLED ONTO THE UNIT WITH A SALINE DIPPED GAUZE IN THE JAWS. THE E-100 GENERATOR WAS FIRED WITH THE YELLOW PEDAL/SYNC ACTIVATION AND CUT/SEAL APPROXIMATELY 100 TIMES. THE UNIT WORKED FINE WITHOUT ANY ISSUE, AND THERE WERE NO ISSUES WITH THE ENERGY OR THE INSTRUMENT USAGE. NO ERRORS WERE FOUND WITHIN THE SYSTEM'S ERROR LOGS." }, { "mdr_text_key": "360493864", "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": "12/26/2024;03/13/2025" } ] }