{ "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": "2955842-2024-10083", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240110", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20231212", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20240111", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230414", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "954410", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240110", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "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": "01/17/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20240110", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20231212", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18489691", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231212", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "339997535", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CUSTOMER CONFIRMED INFORMATION THAT WAS INITIALLY COMMUNICATED. THE CUSTOMER INDICATED THAT SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM, BUT IT WAS UNKNOWN IF THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. DURING THE SETUP OF THE SYSTEM, THE CUSTOMER NOTICED THAT ONE OF THE SURGEON SIDE CONSOLE (SSC) EYES DID NOT WORK AND IT WAS BLACK. THE CUSTOMER LATER CHANGED THE ENTIRE SYSTEM TO FINISH THE SURGERY. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS FOLLOWING THE CANCELLATION OF THE SURGICAL PROCEDURE POST PORT PLACEMENT. THE CUSTOMER REPORTED THAT THE CAUSE OF THE CASE BEING ABORTED WAS DUE TO ONE OF THE SSC EYES NOT WORKING. ISI RECEIVED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HRSV WAS ANALYZED, AND THE ISSUE WAS REPLICATED AND CONFIRMED. THE COMPONENT WAS INSTALLED INTO THE SYSTEM AND UPON STARTUP THE UNIT IMMEDIATELY SHOWED THE ISSUE. THE LEFT HRSV WAS COMPLETELY DOWN AND DID NOT ALLOW FOR ANY VISION TO BE SEEN IN THE USER'S LEFT EYE." }, { "mdr_text_key": "339997536", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "332601424", "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, THE SURGEON CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) PRIOR TO STARTING SURGERY AND REPORTED THAT THE IMAGE WAS MISSING ON THE LEFT EYE IN THE SURGEON SIDE CONSOLE (SSC). THE SURGEON REPORTED THAT THE CUSTOMER POWER CYCLED THE SYSTEM TWICE AND REPLACED THE ENDOSCOPE BEFORE THE CALL, BUT THE FAULT PERSISTED. THE ISI TSE GUIDED THE SURGEON THROUGH A HARD POWER CYCLE WITH EMERGENCY POWER OFF (EPO) OF THE SYSTEM, WHICH DID NOT RESOLVE THE ISSUE. THE ISI TSE GUIDED THE SURGEON THROUGH POWERING DOWN THE SYSTEM, RESEATING THE BLUE FIBER CABLE (BFC) ON THE SSC, AND RESTARTING THE SYSTEM, BUT THIS ALSO DID NOT RESOLVE THE ISSUE. THE ISI TSE ASKED THE SURGEON TO DISCONNECT THE ENDOSCOPE FROM THE EC AND CHECK IF THE COLOR BARS WERE PRESENT ON BOTH EYES IN THE SSC. THE SURGEON DID SO AND REPORTED THAT THE COLOR BARS WERE NOT VISIBLE IN THE LEFT EYE ON THE SSC. THE SURGEON INFORMED THE ISI TSE THAT THEY WERE BRINGING THE SSC FROM ANOTHER SYSTEM INTO THE OPERATING ROOM (OR). THE ISI TSE STAYED ON THE LINE WHILE THE CUSTOMER WAS CONNECTING THE SECOND SSC. THE REPLACEMENT SSC DID NOT CONNECT, AND THE ISI TSE VERIFIED THAT THIS WAS DUE TO THE SECONDARY SSC FROM THE SYSTEM HAVING ANOTHER SOFTWARE VERSION. THE ISI TSE INFORMED THE REPLACEMENT SSC WAS NOT COMPATIBLE. THE SURGEON INFORMED THE ISI TSE THAT THEY WOULD CANCEL THE PROCEDURE. THE PROCEDURE WAS ABORTED POST-ANESTHESIA AND PORT PLACEMENT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "332601425", "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 ISI FSE REPLACED THE LEFT HIGH RESOLUTION STEREO VIEWER (HRSV) DUE TO AN IMAGE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER-REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT HAS NOT BEEN RETURNED FOR FAILURE ANALYSIS EVALUATION. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/15/2024" } ] }