{ "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": "2955842-2024-11762", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240226", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20240129", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240226", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200608", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2000882", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240226", "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": "20240207", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Energy Output Problem", "Energy Output Problem" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "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": "20240226", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20240129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18782605", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240129", "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": "336285409", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE REPORTED EVENT; UNABLE TO REPRODUCE THE FAILURE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. FSE REPLACED E100, SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE E-100 GENERATOR WAS RETURNED FOR FAILURE ANALYSIS. HOWEVER, THE REPORTED FAILURE COULD NOT BE REPLICATED. SECTION D10 CONCOMITANT PRODUCTS: VESSEL SEALER EXTEND INSTRUMENTS (PART NUMBER: 480422-1 BATCH/LOT NUMBER L81231019-0328 SERIAL NUMBER (B)(6)) IS ASSOCIATED WITH THE REPORTED EVENT. SYSTEM LOGS SHOW NO RELATED SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "336285410", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE THE SURGEON MENTIONED THE VESSEL SEALER INSTRUMENT (VSE) WAS NOT WORKING AT ALL. THE CIRCULATING NURSE TRIED TO TROUBLESHOOT THE ISSUE BY UNPLUGGING AND PLUGGING THE CORD OF THE VSE TO THE E100. WHEN SHE WENT TO DO THIS SHE SAW A SPARK AND FELT A SHOCK TO THE VERY PROXIMAL TIP OF THE FIRST DIGIT ON THE RIGHT HAND; ENERGY WAS NOT BEING DELIVERED TO THE VSE AT THIS TIME. AFTER PLUGGING THE CORD BACK INTO THE E100 THE VSE INSTRUMENT BEGAN TO FUNCTION AS NORMAL. THE PROCEDURE WAS COMPLETED AS PLANNED. THE NURSE DESCRIBED THE FEELING AS \"A QUICK SHOCK WHEN YOU TOUCH A LIGHT SWITCH.\" A MARK WAS LEFT SMALLER THAN THE SIZE OF A PENCIL ERASER ON THE TIP/DISTAL PORTION OF FIRST DIGIT; NOW THE SKIN IS PEELING. SHE HAS NO PAIN. SHE DID NOT NEED TO SEE A PHYSICIAN OR MEDICAL TREATMENT DUE TO THE SHOCK EVENT. THE GENERATOR SETTINGS FOR THIS CASE ARE UNKNOWN. NO PHOTOS ARE AVAILABLE." } ], "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": "" } ] }