{ "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": "2955842-2022-12646", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220630", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20210409", "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": "20220630", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190118", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1016958", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220630", "brand_name": "DA VINCI XI", "generic_name": "VISION SIDE SYSTEM, RECONDITIONED", "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": "380721-04", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874115343", "udi_public": "(01)00886874115343", "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", "No Apparent Adverse Event", "Energy Output Problem", "No Apparent Adverse Event" ], "reporter_state_code": "AR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20220630", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "67 YR", "patient_sex": "Female", "patient_weight": "56 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20210409", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14876429", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210409", "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": "295062200", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE INTRAOPERATIVE FAILURE MODE IS UNKNOWN, AND NO PROBLEM WAS DETECTED BASED ON THE INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. LIVE SYSTEM ERROR LOG REVIEW WAS CONDUCTED DURING THE SUPPORT CALL AND THERE WERE NO OBSERVED RELEVANT ERRORS PRESENT IN THE LOGS. A REVIEW OF THE INSTRUMENT LOGS WAS PERFORMED ON (B)(6) 2021 FOR A PROCEDURE ON (B)(6) 2021 ON SYSTEM SK4030. WHILE NOT ALL REUSABLE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES AT THIS TIME, A SITE HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST THOSE INSTRUMENTS. AN ISI FIELD SERVICE ENGINEER (FSE) INVESTIGATION WAS COMPLETED. THE FSE CONFIRMED WITH THE CUSTOMER THAT THE PATIENT WASN'T BLEEDING PROFUSELY, AND NO URGENT ATTENTION WAS REQUIRED. ONCE THE SYSTEM WAS POWERED BACK ON AND THE ERBE GENERATOR STARTED TO FUNCTION NORMALLY, THE SURGEON WAS ABLE TO CONTROL THE BLEEDING AND THE SYSTEM DID NOT ENCOUNTER ANY OTHER ISSUES AFTER SYSTEM RESTART. NO SITE VISIT WAS CONDUCTED AS THE REPORTED ISSUE WAS RESOLVED ON THE PHONE. THE SYSTEM IS IN USE. A REVIEW OF THE SITE'S COMPLAINT HISTORY FOUND THAT THERE WERE NO OTHER COMPLAINTS FOR THIS PRODUCT. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING: DURING A DA VINCI ASSISTED CHOLECYSTECTOMY, IT WAS REPORTED THAT THE ERBE GENERATOR WAS NOT WORKING AS INTENDED. TROUBLESHOOTING WITH DVSTAT WAS INITIATED AND THE GENERATOR BEGAN TO AFTER THE GENERATOR WAS MOVED TO ANOTHER POWER OUTLET. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF ¿LESS THAN A TEASPOON¿ DUE TO THE DELAY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT ADVERSE EFFECTS. IN THIS CASE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE AND INTRAOPERATIVE COMPLICATION REMAINS UNKNOWN." }, { "mdr_text_key": "295062201", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE ¿ENERGY BOX WAS NOT WORKING¿. THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO THEN REACHED OUT TO AN ISI TECHNICAL SUPPORT ENGINEER (TSE). THE CUSTOMER HAD TRIED TO RESEAT THE BIPOLAR ENERGY CABLE MULTIPLE TIMES, TRIED DIFFERENT ENERGY CABLES, AND TRIED TO RESEAT THE INSTRUMENTS MULTIPLE TIMES; ALL WITH NO CHANGE. A MESSAGE HAD PRESENTED ON THE VISION SIDE CART (VSC) TOUCHSCREEN (TS) MONITOR STATING, \"VIO DV IS NOT CONNECTED\" AND A RED QUESTION MARK DISPLAYED WITH AN INCOMPATIBLE INSTRUMENT MESSAGE ON THE ERBE GENERATOR. THE TSE CHECKED THE LIVE SYSTEM LOGS AND DID NOT SEE ANY RELEVANT ERRORS PRESENT IN THE LOGS. THE TSE HAD CUSTOMER RESEAT THE POWER CABLE ON THE BACK OF THE ERBE AND CHECK ERBE CONNECTIONS, BUT ALL FELT SECURE. THE TSE WALKED THE CUSTOMER THROUGH A SYSTEM POWER CYCLE AND THE CUSTOMER MOVED THE ERBE POWER CABLE TO A DIFFERENT OUTLET. THE CUSTOMER THEN POWER CYCLED THE ERBE GENERATOR. THE SYSTEM THEN POWERED ON WITH MONOPOLAR AND BIPOLAR ENERGY WORKING NORMALLY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¿A LITTLE BLEEDING DURING THE SYSTEM DELAY¿ BUT THE AMOUNT AND DETAILS OF BLEEDING WAS NOT PROVIDED. THE PROCEDURE CONTINUED ROBOTICALLY. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, AS THE SURGEON WAS PERFORMING BLUNT DISSECTION OF SOFT TISSUE WITH AN UNSPECIFIED ROBOTIC INSTRUMENT, TRYING TO IDENTIFY AN ARTERY, IT WAS DISCOVERED THAT THERE WAS NO ENERGY GETTING TO ANY OF THE ENERGY INSTRUMENTS. A CASE HAD JUST BEEN COMPLETED PRIOR TO THIS PROCEDURE AND THERE WERE NO ISSUES. HOWEVER, AS THE SURGEON WAS ABOUT HALF-WAY THROUGH THIS PROCEDURE AND TRIED USING A ROBOTIC ENERGY INSTRUMENT FOR THE FIRST TIME DURING THE PROCEDURE, A MESSAGE PRESENTED ON THE VISION SIDE CART (VSC) TOUCHSCREEN (TS) MONITOR STATING, \"VIO DV IS NOT CONNECTED\" AND A RED QUESTION MARK DISPLAYED WITH AN INCOMPATIBLE INSTRUMENT MESSAGE ON THE ERBE GENERATOR. IT WAS NOTED THAT AN UNSPECIFIED ¿LAPAROSCOPIC CAUTERY PENCIL¿ WAS IN USE DURING THIS PROCEDURE. THE CUSTOMER SAID THAT THEY ALWAYS USE A DESIGNATED PORT FOR LAPAROSCOPIC INSTRUMENTS. TO TRY AND RESOLVE THE ISSUE, THE CUSTOMER HAD TRIED TO RESEAT THE BIPOLAR ENERGY CABLE MULTIPLE TIMES, TRIED DIFFERENT ENERGY CABLES, AND TRIED TO RESEAT THE INSTRUMENTS MULTIPLE TIMES; ALL WITH NO CHANGE. THE CUSTOMER THEN CONTACTED AN ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO THEN REACHED OUT TO AN ISI TECHNICAL SUPPORT ENGINEER (TSE) FOR SUPPORT. THE TSE CHECKED THE LIVE SYSTEM LOGS AND OBSERVED NO RELEVANT ERRORS. AFTER RESEATING THE POWER CABLE ON THE BACK OF THE ERBE AND CHECKING ERBE CONNECTIONS, THE ISSUE WAS STILL NOT RESOLVED AS THE CONNECTIONS FELT SECURE. THE ISSUE RESOLVED WHEN THE TSE WALKED THE CUSTOMER THROUGH A SYSTEM POWER CYCLE AND THE CUSTOMER MOVED THE ERBE POWER CABLE TO A DIFFERENT OUTLET. THE CUSTOMER THEN POWER CYCLED THE ERBE GENERATOR. THE SYSTEM THEN POWERED ON WITH MONOPOLAR AND BIPOLAR ENERGY FUNCTIONALITY. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO PATIENT INJURY. THERE WAS ¿LESS THAN TEN MINUTES OF A DELAY¿. IT WAS CONFIRMED THAT THE INITIALLY REPORTED BLEEDING WAS FROM BLUNT DISSECTION OF SOFT TISSUE AS THE SURGEON WAS TRYING TO IDENTIFY AN ARTERY. THE ESTIMATED BLOOD LOSS WAS ¿LESS THAN A TEASPOON, IF THAT¿. IT WAS REPORTED THAT ¿THE SITUATION WAS FRUSTRATING AND PUZZLING¿ BUT THAT IT ¿WAS NOT CRITICAL¿ AND THE PATIENT IS FINE." } ], "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": "" } ] }