{ "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": "2955842-2022-15909", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20221215", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20221114", "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": "20221215", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210712", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1757586", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221215", "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": "380721-10", "catalog_number": "380721", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20221129", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Output Problem", "Output Problem" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20221215", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20221114", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15984321", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221114", "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": "305492620", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A U-02 ERROR OCCURRED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER WENT ONSITE AND REPLACED THE GENERATOR. ISI DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE IESU GENERATOR WAS ANALYZED AND THE COMPLAINT REGARDING THE U-02 ERROR WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE CAUSE OF THIS REPORTED EVENT IS ATTRIBUTED TO COMPONENT FAILURE. A REVIEW OF THE SITE¿S SYSTEM LOGS WAS PERFORMED DURING THE INITIAL TROUBLESHOOTING. NO IMAGES OR PROCEDURE VIDEO WERE PROVIDED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A DA VINCI-ASSISTED PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE AS A RESULT OF ERRORS RELATED TO THE IESU GENERATOR. THE PATIENT TOLERATED THE OPEN PROCEDURE WITH NO REPORTED ISSUES." }, { "mdr_text_key": "305492621", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS INITIALLY REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE THAT A U-02 ERROR OCCURRED AGAINST THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR, SHORTLY AFTER POWERING ON THE GENERATOR. THE SITE TRIED TO POWER CYCLE THE IESU SEVERAL TIMES PRIOR TO CALLING, BUT THE ERROR KEPT RETURNING. THE TECH SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH POWERING DOWN THE SYSTEM AND THE IESU. THE CUSTOMER DISCONNECTED ALL OF THE CABLES AT THE BACK OF THE IESU, THEN POWERED IT ON WITHOUT THE FOOT SWITCHES CONNECTED. THE ERROR SEEMED TO GO AWAY, BUT SOON RETURNED. THERE WERE NO REPORTS OF PATIENT INJURY. AT THIS TIME THE PROCEDURE OUTCOME IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE SURGICAL PORTS HAD BEEN PLACED ON THE PATIENT WHEN THE IESU ERRORS OCCURRED. THE PROCEDURE WAS ULTIMATELY CONVERTED TO AN OPEN PROCEDURE DUE TO THE GENERATOR ISSUE. THERE WAS NO REPORTED HARM TO THE PATIENT AS A RESULT OF THE CONVERSION." } ], "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": "" } ] }