{ "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": "2955842-2024-19813", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20240925", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20240829", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20240925", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210121", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1304064", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240925", "brand_name": "DA VINCI XI", "generic_name": "SURGEON SIDE CONSOLE, 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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380723-11", "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": "00886874115374", "udi_public": "(01)00886874115374", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "No Display/Image", "No Display/Image" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/11/2024;10/21/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": "20240925", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "73 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240829", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20306621", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240829", "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": "352680559", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY SURGICAL PROCEDURE, A SURGEON CALLED IN AFTER PORT PLACEMENT AND BEFORE INSTALLING ANY INSTRUMENT TO REPORT THAT THE RIGHT EYE ON THE SURGEON CONSOLE (SSC) WAS BLACK. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF ICONS WERE DISPLAYED, WHICH WAS NOT THE CASE. THE SURGEON WAS VERY NERVOUS AND WANTED TO HAVE AN IMMEDIATE SOLUTION. THE TSE GUIDED THE SURGEON TO CHECK BOTH VIDEO CHANNELS ON THE TSC (TOUCHSCREEN): BOTH EYES WERE DISPLAYING PROPERLY. THE TSE GUIDED THE SURGEON TO PERFORM A HARD POWER CYCLE OF THE SSC, UNPLUGGING THE SSC POWER CORD FROM THE WALL FOR 1 MINUTE, AND, JUST IN CASE, RESEATING THE SSC BFC (BLUE FIBER CABLE). THIS DID NOT BRING ANY IMPROVEMENT. THE TSE GUIDED THE SURGEON TO CHANGE THE HIGH-RESOLUTION STEREO VIEWER (HRSV) POSITION, EXTREME UP, AND EXTREME DOWN: THIS DID NOT HAVE ANY IMPACT EITHER. LIVE LOGS WERE CLEAN. THE SURGERY WAS POSTPONED. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM'S FUNCTIONALITY WAS INSPECTED WHEN IT WAS POWERED ON. NO ERROR MESSAGE WAS DISPLAYED, AND THE SYSTEM POWERED ON WITH NO ERRORS. THE PATIENT WAS PUT TO SLEEP AND HAD TROCARS INSERTED, PERITONEAL INSUFFLATED, AND TROCAR PORTS WITHOUT HAVING UNDERGONE SURGERY CLOSED. THERE WAS A RISK OF A SURGICAL APPROACH IN GENERAL ANESTHESIA DUE TO SYSTEM FAILURE WITH NO ERROR MESSAGE. THIS FORCED THE SURGICAL STAFF TO STOP THE PROCEDURE." }, { "mdr_text_key": "352680560", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE WENT ON SITE, CONFIRMED THE ISSUE WITH ONE EYE MISSING AND REPLACED CFG PERSONALITY MODULE SURGEON CONSOLE (PMSC) AND HIGH-RESOLUTION STEREO VIEWER (HRSV) MONITOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "355187109", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WAS ANALYZED AND FOUND TO HAVE NO FAILURE. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM AND RUN VIDEO TEST, 10 MINUTES SINE CYCLE, 10 POWER CYCLES AND SITTING IDLE FOR 1 HOUR. THE SYSTEM CAME UP WITH NO ERRORS REPORTED AND AUDIO AND VIDEO WERE CLEAR. THE TECHNICIAN COULD NOT REPLICATE THE REPORTED ISSUE. IN ADDITION, THE PMSC WAS LEFT IDLE/TEST WITH OTHER UNITS FOR OVER 40 HOURS. NO PROBLEM FOUND." }, { "mdr_text_key": "355187110", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "354485503", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HIGH-RESOLUTION STEREO VIEWER (HRSV) WAS ANALYZED AND FOUND TO HAVE FAILURE. DURING IN-HOUSE TESTING THE MONITOR WAS INSTALLED AND TESTED IN THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE UNIT STARTED UP AND FAILED WITHOUT VIDEO ON THE DISPLAY. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS. ISI ALSO RECEIVED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "354485504", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "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": "10/18/2024;10/25/2024" } ] }