{ "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": "2955842-2023-12084", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230420", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230328", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20230420", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200817", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1746353", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230420", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM CART", "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": "380941-34", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230412", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114742", "udi_public": "(01)00886874114742", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/28/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20230420", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230328", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16777693", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230328", "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": "313663890", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE MONOPOLAR ENERGY WAS NOT WORKING. THE SITE KEPT GETTING MESSAGES TO CHECK THE MONOPOLAR ENERGY CORD, THE INSTRUMENT TIP, AND/OR SHEATH. THE SITE TRIED THREE DIFFERENT ENERGY CORDS, THREE INSTRUMENTS, THREE TIPS, AND TWO SHEATHS, ALL WITH DIFFERENT MESSAGES AND NO MONOPOLAR ENERGY. THE SITE DID A POWER CYCLE OF THE SYSTEM, AND VISION SIDE CART (VSC) BREAKER, WITH NO CHANGE. THE SITE HAD AN ORANGE INSTRUMENT CORD LED ON THE ENERGY SHIELD CONSTANTLY. THE SITE RESEATED THE CORD FROM THE ENERGY SHIELD TO THE ERBE GENERATOR WITH NO CHANGE. THE SITE SWAPPED OUT THE SYSTEM FOR AN XI SYSTEM AND ENDED THE CALL. THERE WERE NO REPORTS OF PATIENT INJURY." }, { "mdr_text_key": "313663891", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MONOPOLAR ENERGY WAS NOT WORKING, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND PLUGGED THE SUSPECTED INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) INTO A DEDICATED AC OUTLET WITH A MONOPOLAR INSTRUMENT INSTALLED. THE CORD SENSOR ON THE EMBEDDED SERIALIZER FOR MASTER (ESM) WAS INTERMITTENT BETWEEN BLUE AND ORANGE. THE FSE REPLACED THE ESM TO RESOLVE THE ISSUE. THE FIBER OPTIC CABLE ASSEMBLY WAS REPLACED AS WELL, WHICH IS A SCRAP PART. ISI RECEIVED THE ESM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS REPRODUCED THE CUSTOMER REPORTED COMPLAINT. THE MONOPOLAR INTERMITTENTLY NOT WORKING WHEN FA CONNECT THE CABLE INTO MONOPOLAR CONNECTOR. WHEN FA WIGGLED THE CABLE, THE CORE LED TURN GREEN BUT WHEN RELEASE THEN TURN BACK TO AMBER (SHOULD BE GREEN WHEN CABLE IS CONNECTED). THE FRONT ENCLOSURE ESM WILL BE REPLACED. THE COMPLAINT REGARDING THE MONOPOLAR ENERGY NOT WORKING WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF MONOPOLAR ENERGY NOT WORKING WAS ATTRIBUTED TO COMPONENT FAILURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) CONTRIBUTED TO THE PROCEDURE BEING CONVERTED TO ANOTHER DA VINCI SYSTEM. ALTHOUGH NO PATIENT HARM WAS REPORTED, IF THE ALLEGED MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "335320157", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL DETAILS WERE OBTAINED REGARDING THE RELATED EVENT. THE SITE CONVERTED THE PROCEDURE FROM A SINGLE PORT (SP) SYSTEM TO A MULTI-PORT XI SYSTEM. CONVERTING THE PROCEDURE FROM AN SP SYSTEM TO AN XI SYSTEM INDICATES THAT EXTRA PORTS HAD TO BE PLACED." } ], "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": "04/26/2023" } ] }