{ "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": "2955842-2025-01488", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250213", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250116", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250213", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190124", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1295330", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250213", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380941-33", "catalog_number": "380941", "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": "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/21/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250213", "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": "20250116", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21379562", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250116", "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": "366020969", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ENDOSCOPE CONTROLLER (EC) WAS ANALYZED AND FOUND TO HAVE CAMERA ERRORS. UPON VISUAL INSPECTION, THE METAL PLATE OF THE DUAL CAMERA INTERFACE BOARD (DCIB) PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS SLIGHTLY DAMAGED AT THE TOP, WHICH WAS CAUSING THE REPORTED FAILURE. THE RETURNED ENDOSCOPE PASSED THE SELF-TEST WITH NO ISSUES. COMMUNICATION ERRORS WERE NOT REPLICATED DURING IN-HOUSE TESTING; NO ERROR MESSAGE WAS OBSERVED. THE CAMERA PASSED ALL THE QAP (QUALITY ASSURANCE PROCEDURE) TESTING. THERE WAS NO PROBLEM DETECTED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: CAMERA POWER WARNING (POWER ON: MEASURED VOLTAGE OUT OF RANGE) AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE DCIB WAS THE ROOT CAUSE OF THE REPORTED FAILURE." }, { "mdr_text_key": "366020970", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "363617682", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, TWO ENDOSCOPES EXHIBITED ERRORS WHEN THEY WERE CONNECTED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED ERRORS BEING REPORTED ON TWO ENDOSCOPES. THE CUSTOMER NOTED THAT THE SURGEON OBSERVED THAT THE SECOND ENDOSCOPE WAS DIFFICULT TO PUSH INTO THE ENDOSCOPE CONNECTOR (EC), BUT THE FIRST ENDOSCOPE CONNECTED EASILY. THE CUSTOMER WAS WAITING FOR A THIRD ENDOSCOPE TO BE DELIVERED FROM REPROCESSING, BUT THE DELIVERY WAS DELAYED. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE SURGICAL PROCEDURE FROM A SINGLE PORT PROCEDURE TO A MULTI-PORT PROCEDURE." }, { "mdr_text_key": "363617683", "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 FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS NOT ABLE TO REPRODUCE THE REPORTED COMPLAINT. THE FSE REPLACED THE ENDOSCOPE CONTROLLER (EC) AS A PRECAUTION TO CORRECT ISSUES WITH CAMERA ERRORS THE FSE INSPECTED THE TWO SUSPECT ENDOSCOPES USED AS PART OF SYSTEM VERIFICATION. THE FSE NOTED THAT ONE ENDOSCOPE WAS WORKING AS INTENDED. THE FSE CONFIRMED THE ISSUE OF THE SECOND ENDOSCOPE BEING DIFFICULT TO INSERT INTO THE EC PORT. THE FSE VERIFIED THAT THE SYSTEM WAS READY FOR USE. ISI HAS NOT RECEIVED THE EC INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. ISI HAS RECEIVED THE ENDOSCOPE (PART #430077-05, SERIAL #(B)(6)) FOR FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE AS OF THE DATE OF THIS REPORT. THE EVENT INVESTIGATION IS IN PROGRESS." } ], "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": "03/17/2025" } ] }