{ "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": "2955842-2024-18674", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240828", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20240730", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240828", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "191648", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240828", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "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": "20240816", "device_report_product_code": "NAY", "device_age_text": "", "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": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20240828", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "50 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20240730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20087447", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240730", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "350390316", "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) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE WAS ABLE TO REPRODUCE A NON-RECOVERABLE E-100 GENERATOR ERROR AND REPLACED THE UNIT. THE SYSTEM WAS THEN TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE E-100 GENERATOR ASSOCIATED WITH THIS COMPLAINT. THE REPORTED FAILURE WAS REPLICATED. THIS UNIT WAS INSTALLED ONTO THE TEST SYSTEM AND FAILED TESTING. THE UNIT ON FIRST POWER CYCLE DID NOT HAVE AN LED PRESENT FOR THE INSTRUMENT PORT. AFTER A MINUTE, THE UNIT WOULD FAULT AND AN ERROR WOULD PRESENT IN THE ERROR LOGS. AFTER HARD POWER CYCLING, THE UNIT PRESENTED THE SAME ISSUE. THE UNIT WAS NOT PRESENT ON THE VISION SIDE CART (VSC) TROUBLESHOOTING PANEL. A REVIEW OF THE LOGS FOR THE VESSEL SEALER EXTEND (VSE) INSTRUMENT ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. THE LOGS SHOW THAT THE VSE INSTRUMENT WAS INSTALLED 9 TIMES AND PASSED HOMING 9 TIMES. THERE WERE 87 CUT COMPLETE EVENTS AND 114 SEAL EVENTS NOTED. NO E-100 LOGS WERE SEEN AS AN ERBE GENERATOR WAS USED WITH THIS INSTRUMENT. THE INSTRUMENT WAS USED FOR ABOUT AN HOUR. NOTHING IN THE LOGS POINT TO A VSE INSTRUMENT RELATED ERROR. THE E-100 GENERATOR WAS NOT USED WITH THE INSTRUMENT. REFER TO MEDWATCH REPORT (MDR) WITH MFR REPORT #2955842-2024-18024 FOR MDR SUBMISSION OF THE SAME EVENT REPORTED AGAINST THE VSE INSTRUMENT." }, { "mdr_text_key": "350390317", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT REQUIRED A SUBSEQUENT PROCEDURE DUE TO BLEEDING. THE SURGEON INITIALLY UTILIZED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WITH AN E-100 GENERATOR. IT WAS REPORTED THAT THE E-100 GENERATOR KEPT FAULTING WITH A MESSAGE TO CHECK THE CABLE CONNECTIONS. THE CUSTOMER ALSO REPORTED BLEEDING DUE TO INTERMITTENT ENERGY FROM THE E-100 GENERATOR. THE CUSTOMER CHANGED OUT THE VSE INSTRUMENT AND POWER CYCLED THE E-100 GENERATOR BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER THEN SWITCHED TO AN ERBE GENERATOR FOR THE REMAINDER OF THE PROCEDURE, SPECIFICALLY ON VESSELS WITHIN THE MESENTERY AND ALONG THE ILEUM. IT WAS NOTED THROUGHOUT THE PROCEDURE, THE VSE INSTRUMENT MADE THE PROPER SEALING TONES AND NO ERROR MESSAGES WERE PRODUCED. HOWEVER, THE SURGEON STATED THE SEALING TIME TOOK LONGER THAN NORMAL ON MOST SEALING ATTEMPTS. ONCE THE SEALING WAS COMPLETE, THE VESSELS LOOKED FULLY SEALED AND NO ADDITIONAL BLEEDING OCCURRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO COMPLICATIONS AND THE PATIENT WAS NOTED TO BE \"DRY.\" WITHIN FIFTEEN MINUTES IN THE POST ANESTHESIA CARE UNIT (PACU) THE PATIENT BECAME HYPOTENSIVE, AND BLEEDING WAS IDENTIFIED. THE PATIENT RETURNED TO THE OPERATING ROOM FOR AN EMERGENCY OPEN LAPAROTOMY. BLEEDING WAS FOUND WITHIN THE SEALED VESSELS, SPECIFICALLY MESENTERY AND ALONG THE ILEUM WHICH WERE NOTED TO BE DRY AT THE END OF THE ROBOTIC PROCEDURE. THE SURGEON BELIEVES THE PATIENT MIGHT HAVE COUGHED OR SNEEZED AND POPPED THE VESSELS OPEN THAT WERE NOT EFFICIENTLY SEALED. THE ESTIMATED BLOOD LOSS WAS 7 LITERS, THE PATIENT RECEIVED A MASS TRANSFUSION PROTOCOL, AND AN ESTIMATED 20 UNITS OF PRODUCTS WERE ADMINISTERED. THE PATIENT IS RECOVERING WELL, AND WAS HOSPITALIZED FOR AN ADDITIONAL TWO DAYS." } ], "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": "" } ] }