{ "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": "2955842-2024-21724", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241112", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20241014", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "IN", "manufacturer_contact_area_code": "408", "date_added": "20241113", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230428", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "974996", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241112", "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": "OTHER", "model_number": "380723-15", "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": "12/10/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20241112", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20241014", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20669841", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241014", "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": "356493685", "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 EVENT. THE FSE WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE WHICH WAS FOUND TO BE INTERMITTENT. THE FSE REPLACED THE HRSV MONITOR AND PERSONALITY MODULE SURGEON CONSOLE (PMSC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS." }, { "mdr_text_key": "356493686", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED NO VISION IN THE RIGHT EYE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV). THE SYSTEM HAD INITIALLY POWERED ON WITH NO ISSUES, AND THE TOUCHSCREEN VISION WAS FINE FOR BOTH THE LEFT AND RIGHT EYE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED A HARD POWER CYCLE THE SURGEON SIDE CONSOLE (SSC); THE RIGHT EYE VISION WAS RESTORED BUT THE LEFT EYE VISION WAS BRIGHTER THAN THE RIGHT EYE. AS A RESULT OF THE CUSTOMER REPORTED ISSUE, THE SURGEON DECIDED TO ABORT THE PROCEDURE. INCISION PORTS HAD ALREADY BEEN PLACED ON THE PATIENT." }, { "mdr_text_key": "361760369", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "361760370", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) ALSO REPLACED TWO HIGH RESOLUTION STEREO VIEWERS (HRSV). ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HRSV 1 WAS ANALYZED AND FOUND TO HAVE NO FAILURE. DURING AN IN-HOUSE TESTING, THE MONITOR WAS INSTALLED ON PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE UNIT STARTED UP WITHOUT ANY ERRORS. THE IMAGE QUALITY WAS SHARP, NO NOISE, AND NOT TINTED. THE SYSTEM IDLED FOR 1 HOUR AND VISUALLY VERIFIED THAT THERE WERE NO ISSUES. THE REPORTED PROBLEM COULD NOT BE REPLICATED. THE HRSV2 WAS ANALYZED AND FOUND TO HAVE NO FAILURE. DURING THE TESTING, THE MONITOR WAS INSTALLED ON AN IN-HOUSE TEST SYSTEM. THE UNIT STARTED UP WITHOUT ANY ERRORS. THE IMAGE QUALITY WAS SHARP, NO NOISE, AND NOT TINTED. DURING VISUAL INSPECTION, IT WAS NOTICED THAT THE WHOLE UNIT WAS CONTAMINATED WITH DUST PARTICLES. PART OF THE LABEL STICKER WAS SCRATCHED OFF. THE REPORTED PROBLEM COULD NOT BE REPLICATED. THE MONITOR AND PERSONALITY MODULE SURGEON CONSOLE (PMSC) WAS ANALYZED AND FOUND TO HAVE A FAILURE ON THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC). THE PMSC WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE REPORTED ISSUE WAS TRIGGERED INDICATING FAULT ON THE VIDEO BRANCH (VBR) BOARD, REPLICATING THE REPORTED EVENT. A VISUAL INSPECTION HAD SHOWN THAT THE CHIP ON THE VBR WAS BROKEN." } ], "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": "01/02/2025" } ] }