{ "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": "2955842-2025-38925", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250923", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250827", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "AU", "manufacturer_contact_area_code": "408", "date_added": "20250923", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241008", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "750215", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250923", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE 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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-50", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/08/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260120", "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": "20250923", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20251204", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23121149", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250827", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "390661086", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CANNULA MOUNT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN THE SYSTEM LOGS, CANNULA SENSOR ERRORS WERE SEEN, CONFIRMING THE FAULT OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, NO ISSUES WERE SEEN THAT WOULD BE RELATED TO THE REPORTED EVENT. THE COMPONENT WAS INSTALLED ONTO A TEST SYSTEM WHERE IT HAD FUNCTIONED AS DESIGNED. MULTIPLE CANNULA'S WERE INSTALLED; HOWEVER, NO FAULTS OR ERRORS WERE TRIGGERED. THE COMPONENT WAS THEN LEFT TO IDLE WITH A CANNULA INSTALLED FOR ABOUT 2 HOURS BUT NO FAULTS OR ERRORS WERE TRIGGERED. THE EVENT WAS CONFIRMED BASED ON ERROR LOG REVIEW; HOWEVER, THE ISSUE WAS NOT ABLE TO BE REPLICATED DURING IN-HOUSE TESTING. NO PRODUCT ISSUE WAS IDENTIFIED." }, { "mdr_text_key": "390661087", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "380730831", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE REPORTED EVENT FURTHER. THERE WERE SIGNS OF FLUID INSIDE THE CANNULA MOUNT AND BOARDS. THE PROBLEM WAS REPRODUCED. A SINGLE PORT (SP) CANNULA ID (SCID) LOW POWER UNIT (LPU) EXCHANGE WAS PERFORMED, AND THE CANNULA MOUNT WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER-REPORTED ISSUE." }, { "mdr_text_key": "380730832", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY PROSTATECTOMY RADICAL SURGICAL PROCEDURE USING A SINGLE PORT (SP) SYSTEM, WITH THE PATIENT ALREADY UNDER ANESTHESIA, A REPEATED ERROR FROM THE CANNULA SENSOR WAS OBSERVED BEFORE DOCKING TO THE PATIENT, WHICH WAS REPORTED TO AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE TSE REVIEWED THE ERROR LOGS BUT HAD NO LIVE LOGS. WHEN INSTALLING THE CANNULA, THE CANNULA WAS NOT RECOGNIZED. THERE WERE SEVERAL SYSTEM POWER CYCLES WITH AND WITHOUT EMERGENCY POWER OFF; HOWEVER, THE ERRORS PERSISTED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." } ], "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": "12/04/2025" } ] }