{ "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": "2955842-2023-19387", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20231019", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20230922", "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": "FR", "manufacturer_contact_area_code": "408", "date_added": "20231019", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211013", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2053852", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231019", "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": "380721-11", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20231012", "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": "10/23/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "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": "20231019", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230922", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17965009", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230922", "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": "338358350", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "338358351", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION ON THE ISI CORE CONTROLLER (ICC). THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT REPRODUCE. THE PRINTED CIRCUIT ASSEMBLY (PCA) TECHNICIAN WAS UNABLE TO REPRODUCE THE FAILURE REPORTED BY INSTALLING THIS BOARD INTO PCA TEST SYSTEM. THE SYSTEM STARTED UP WITH NO ERROR THEN 50X POWER CYCLES WERE RUN WITH THIS BOARD, AND ALL PASSED. THE ICC REMAINED IN THE TEST SYSTEM FOR 5 DAYS, WHILE TESTING OTHER PARTS, AND IT PERFORMED WITH NO ISSUE. THE PROBLEM COULD NOT BE REPLICATED." }, { "mdr_text_key": "326033068", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR 90 AND PROCEDURE WAS ABORTED AFTER PORTS WERE PLACED ON THE PATIENT, AN INVESTIGATION IS IN PROGRESS 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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE ISI CORE CONTROLLER (ICC). SYSTEM WAS TESTED AND WAS READY FOR USE. ISI HAS RECEIVED THE ICC, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN ISI TECHNICAL SUPPORT ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERROR CODE 90 - MASTER SUPERVISORY CONTROLLER (MSC) SAW OUT-OF-RANGE VOLTAGE ON CHANNEL 1, 12V." }, { "mdr_text_key": "326033069", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY RADICAL WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED A NON-RECOVERABLE FAULT. TSE VIEWED THE SYSTEM EVENT LOGS AND COULD SEE AN ERROR CODE 90 POINTING THE ISI CORE CONTROLLER (ICC) BOARD. TSE ASKED HIM TO SHUT DOWN THE SYSTEM AND CYCLE THE VISION SIDE CART (VSC) BREAKER. AFTER RESTARTING THE ERROR REMAINED. AFTER A SECOND ATTEMPT, SAME ISSUE. SURGEON DECIDED TO POSTPONE THE SURGERY, IT WILL NOT BE CONVERTED. THE SYSTEM WAS DOWN. ISI CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE PROCEDURE HAD JUST STARTED, TROCARS IN PLACE AND SOME COLONIC ADHESIONS RELEASED WHEN THE ERROR APPEARED. THE PROCEDURE WAS POSTPONED BECAUSE IT HAD NOT REALLY STARTED AND, AS THE PATIENT WAS OBESE, IT WAS PREFERABLE TO DO IT UNDER ROBOTIC ASSISTANCE. PRE-OP INSPECTION, NO PROBLEMS. NO HARM TO THE PATIENT, APART FROM EXPLORATORY LAPAROSCOPY, NO COMPLICATIONS." } ], "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": "11/18/2023" } ] }