{ "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": "2955842-2026-19866", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260331", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20260305", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "IN", "manufacturer_contact_area_code": "", "date_added": "20260331", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210726", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "803693", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260331", "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": [ "Display or Visual Feedback Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/10/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260528", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260331", "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" ] } ], "distributor_city": "", "date_report": "20260430", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24743432", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260305", "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": "397057199", "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 SWAPPED THE HIGH RESOLUTION STEREO VIEWER (HRSV) MONITOR CABLE FROM THE RIGHT TO THE LEFT EYE TO ISOLATE THE ISSUE. THE PROBLEM SHIFTED WITH THE MONITOR CABLE, INDICATING THAT THE HRSV ITSELF WAS FUNCTIONING PROPERLY AND THAT THE ISSUE WAS RELATED TO THE PERSONALITY MODULE SURGEON CONSOLE (PMSC). THE PMSC WAS REPLACED, AND 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." }, { "mdr_text_key": "397057200", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED PROCEDURE, THE RIGHT EYE VISION OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV) ON THE SURGEON SIDE CONSOLE (SSC) APPEARED PINK. AN INITIAL SYSTEM POWER CYCLE WAS ATTEMPTED TO RESOLVE THE ISSUE, BUT THE PROBLEM PERSISTED. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND RECOMMENDED PERFORMING ANOTHER POWER CYCLE AND RESEATING THE BLUE FIBER CABLE (BFC) ON THE SSC. HOWEVER, THE VISION ISSUE WAS NOT RESOLVED. AS A RESULT, THE SURGERY WAS CONVERTED TO A MINIMALLY INVASIVE CARDIAC SURGERY (MICS) CORONARY ARTERY BYPASS GRAFTING (CABG). THE PATIENT TOLERATED THE CHANGE WELL, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED." }, { "mdr_text_key": "400004413", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: D9, G3, G6, H2, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) FOR FAILURE ANALYSIS EVALUATION. THERE WERE NO ERRORS THAT WERE IDENTIFIED IN THE LOGS TO CONFIRM THE REPORTED EVENT IN THE FIELD. A VISUAL INSPECTION REVEALED NO ISSUES RELATED TO THE EVENT. THE UNIT WAS INSTALLED ON A SURGEON SIDE CONSOLE (SSC) AND RECOGNIZED BY THE SYSTEM. THE PMSC WAS TESTED AND POWER CYCLED 10 TIMES WITHOUT ANY RELATED ISSUES OBSERVED. THE UNIT WAS ALSO TESTED USING AN EXTERNAL VIDEO CART MONITOR AND WITH TILEPRO, AND IT FUNCTIONED AS EXPECTED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, AN ISSUE OCCURRED AFTER PORT PLACEMENT, BUT IT IS UNCLEAR WHAT SURGICAL TASK WAS UNDERWAY AT THE TIME. THERE WAS NO PATIENT INJURY OR BLEEDING. THE FOLLOWING DETAILS REMAIN UNKNOWN: POSTOPERATIVE COMPLICATIONS, CONCERNS FOR LONG-TERM COMPLICATIONS, AND THE PATIENT¿S CURRENT STATUS." }, { "mdr_text_key": "400004414", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO 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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/30/2026" } ] }