{ "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": "2955842-2023-17481", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230803", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230710", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230803", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20201216", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "325895", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230803", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "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": "380601-40", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230717", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20230803", "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": "20230710", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17449832", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230710", "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": "320289212", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT A RECOVERABLE FAULT WAS REOCCURRING EACH TIME THE RECOVER FAULT WAS SELECTED. THE SYSTEM WAS NOT AVAILABLE ON ONSITE AND THE CUSTOMER EMAILED EVENT LOG IMAGE TO THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE). THE EVENT LOG IMAGE CONFIRMED ERROR 32100 AND INDICATED THAT THE ERROR WAS REPORTED BY SOAM-A AND POINTED TO THE EGM YAW BRAKE CURRENT IN THE YAW MOTOR ASSEMBLY. THE TSE RECOMMENDED TO PERFORM AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC), BUT THE ERROR PERSISTED. THE CUSTOMER STATED THAT THEY WERE GOING TO ATTEMPT TO CONVERT THE PROCEDURE TO MULTIPORT, USING THEIR XI SYSTEM. THE PROCEDURE WAS CONVERTED FROM A SINGLE-PORT SYSTEM TO AN XI DA VINCI SYSTEM. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "320289213", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED RECOVERABLE ERRORS, 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 EVENT. FSE FOUND ERROR 32100 PRIOR TO REPLACING THE MOTOR. FSE FIRST REPLACED CFG SOAM UNIT, BUT THE REPLACEMENT DID NOT FIX THE ISSUE. THE FSE WAS ABLE TO REPLICATE ERROR AND REPLACED THE MOTOR MODULE AXIS ON THE PATIENT SIDE CART (PSC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE CFG-SOAM INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA) INVESTIGATIONS. FA WAS NOT ABLE TO REPRODUCE THE REPORTED COMPLAINT. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM AND RAN 10 POWER CYCLES AND SAT IDLE FOR 1 HOUR WITH NO ISSUES. ISI DID RECEIVE THE MOTOR MODULE AXIS INVOLVED WITH THIS COMPLAINT TO PERFORM FA, BUT THE ISSUE COULD NOT BE REPRODUCED. THE FAILURE WAS VERIFIED THROUGH FIELD LOGS. THE UNIT UNDERWENT TESTING ON THE PSC FIXTURE TEST PLATFORM (PFTP) AND SUCCESSFULLY INITIALIZED AND PASSED THE BRAKE TEST. ILOOP TWANG AND SERVO TESTS WERE ALSO CONDUCTED, BUT THEY FAILED DUE TO ERROR 23038, WHICH IS UNRELATED TO THE REPORTED ISSUE OF 32100. THE BRAKE COIL WILL BE REPLACED AS A PRECAUTION." } ], "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": "" } ] }