{ "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": "2955842-2023-11901", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230412", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20230320", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20230412", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200727", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2257867", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230412", "brand_name": "DA VINCI XI", "generic_name": "VISION SIDE SYSTEM, 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": "380721-09", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230405", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874115343", "udi_public": "(01)00886874115343", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/28/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20230412", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230320", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16723284", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230320", "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": "335427528", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REDUNDANT POWER TRAY ASSEMBLY WAS ANALYZED AND THE REPORTED FAILURE OF ERROR 86 WAS REPLICATED. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM, AND IT FAILED WITH ERROR 86 DUE TO 10 POWER CYCLES. BOTH POWER SUPPLIES WERE GOOD. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE INTUITIVE POWER DISTRIBUTION (IPD) BOARD WAS CAUSE THE ISSUE. THE IPD BOARD WILL BE REPLACED TO CORRECT THE ISSUE. UPON VISUAL INSPECTION, THE UNIT WAS IN GOOD CONDITION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE IS ATTRIBUTED TO A DEFECTIVE REDUNDANT POWER TRAY ASSEMBLY. THE FSE REPLACED THE PART TO RESOLVE THE ISSUE. FAILURE ANALYSIS ESTABLISHED A COMPONENT FAILURE OF THE IPD BOARD, WILL BE REPLACED TO RESOLVE THE ISSUE." }, { "mdr_text_key": "313111442", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A NON-RECOVERABLE ERROR, 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 FSE REPLACED THE CORE REDUNDANT POWER TRAY ASSEMBLY TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT REGARDING THE NON-RECOVERABLE ERROR WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. ISI HAS RECEIVED THE REDUNDANT POWER TRAY ASSEMBLY; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A DEFECTIVE REDUNDANT POWER TRAY ASSEMBLY. THIS IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER ABORTED AFTER THE START OF THE PROCEDURE DUE TO A NON-RECOVERABLE ERROR. PORTS WERE ALREADY PLACED IN THE PATIENT." }, { "mdr_text_key": "313111443", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AT THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, POST-ANESTHESIA AND PORT PLACEMENT, THE SURGICAL TEAM HAD A NON-RECOVERABLE ERROR 86. PRIOR TO CALLING, THE CUSTOMER PERFORMED A REBOOT OF THE VISION SIDE CART (VSC) CIRCUIT BREAKER, BUT THE PROBLEM PERSISTED. THE TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THE CUSTOMER ABOUT THE ROOT CAUSE FOR THE ISSUE, WHICH WAS A FAULTY POWER BOARD IN THE CORE OF THE VSC. THE SYSTEM WAS NOT USABLE ANYMORE. THE PROCEDURE WAS ABORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED WHEN THE SYSTEM WAS POWERED ON AND THE SYSTEM STARTED WITHOUT PROBLEMS, THE STERILE COVERING OF THE ARMS WAS PERFORMED WITHOUT ISSUES, AND THERE WERE NO ERROR MESSAGES. OPEN SURGERY WAS NOT PERFORMED, THE SURGERY WAS CANCELLED. THE FIRST TROCAR WAS ALREADY PLACED, THEN SUDDENLY THE ERROR MESSAGE APPEARED. IT WAS A SUDDEN OCCURRENCE OF THE ERROR MESSAGE WITHOUT PREVIOUS USE OF THE ROBOT, AS ONLY THE OPTICS WERE USED MANUALLY. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT WAS SCHEDULED FOR ROBOTIC-ASSISTED RADICAL PROSTATECTOMY. THE TECHNICAL PROBLEM OCCURRED BEFORE THE SYSTEM DOCKING. AS A RESULT, THE OPERATION WAS STOPPED IN ORDER NOT TO TAKE AWAY THE ADVANTAGES OF A MINIMALLY INVASIVE OPERATION FROM THE PATIENT, AS THE MAIN OPERATION HAD NOT YET BEGUN, ONLY THE PREPARATIONS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITHOUT ANY COMPLAINTS (NO COMPLICATIONS) AND WITH A NEW SURGERY DATE." } ], "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": "05/22/2023" } ] }