{ "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": "2955842-2023-17647", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230811", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230711", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230811", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1084334", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230811", "brand_name": "DA VINCI ENERGY", "generic_name": "E-100 GENERATOR", "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": "378848", "catalog_number": "378848", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230714", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874119051", "udi_public": "(01)00886874119051", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Energy Output Problem", "Energy Output Problem" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/16/2023", "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": "20230811", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20230711", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17506806", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230711", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "336895208", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336895209", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CONCOMITANT PRODUCT: VESSEL SEALER EXTEND (VSE) INSTRUMENT - PART NUMBER: 480422-1/ LOT: L82230513-0253." }, { "mdr_text_key": "320865151", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY, THERE WAS BLEEDING AFTER USING THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WITH THE E-100 GENERATOR. IT WAS LEARNED THROUGH FOLLOW UP WITH THE ROBOTICS COORDINATOR (ROCO) THAT THIS OCCURRED WHILE SEALING IN AN UNSPECIFIC LOCATION IN THE PELVIS AFTER THE INSTRUMENT WAS SUCCESSFULLY USED EARLIER IN THE PROCEDURE. THERE WAS NO TISSUE EFFECT OBSERVED YET THE SURGEON RECEIVED A SEAL COMPLETE MESSAGE. AFTER THE SEAL, THE TISSUE STILL BLED AND THERE WERE NO ERRORS. AN UNSPECIFIED CAUTERY INSTRUMENT WAS USED TO CONTROL THE \"OOZING\" AND ACHIEVE HEMOSTASIS. NO OTHER MEDICAL INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY." }, { "mdr_text_key": "320865152", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INSUFFICIENT SEAL IS UNKNOWN; HOWEVER, THE SURGEON BELIEVES THE CAUSE TO BE THE GENERATOR. THE E-100 GENERATOR WAS REPLACED AND RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS (FA) BUT THE REPORTED FAILURE COULD NOT BE REPLICATED. THE GENERATOR WAS INSTALLED INTO THE TEST SYSTEM AND A SALINE-DIPPED GAUZE WAS PLACED IN THE JAWS OF AN ENERGY INSTRUMENT AND FIRED ABOUT 100 TIMES WITHOUT AN ISSUE. CONCOMITANT PRODUCT: VESSEL SEALER EXTEND (VSE) INSTRUMENT - LOT: L82230513-0253. ADVANCED ENERGY LOGS SHOW THAT THE VSE INSTRUMENT WAS INSTALLED TWICE AND PASSED HOMING EACH TIME AND 31 CUT COMPLETE EVENTS WERE RECORDED WITH NO ERRORS. E-100 LOGS SHOW 34 SEAL EVENTS WITH NO ERRORS. SYSTEM LOGS ALSO DO NOT SHOW ANY ERRORS. THE INSTRUMENT WAS USED FOR A LITTLE OVER 8 MINUTES. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) FOR SUBMISSION OF A SIMILAR INCIDENT INVOLVING THIS E-100 GENERATOR THAT OCCURRED THE DAY PRIOR." } ], "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": "09/12/2023" } ] }