{ "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. 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(ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON SITE AND CONFIRMED THE IESU GENERATOR FAULT ENCOUNTERED BY THE CUSTOMER ON STARTUP. THE FSE REPLACED THE IESU GENERATOR TO RESOLVE THE ISSUE WITH GENERATOR FAULTING. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE IESU GENERATOR FOR FAILURE ANALYSIS EVALUATION. THE IESU GENERATOR WAS ANALYZED AND THE \"ACTIVATION HAS BEEN INTERRUPTED\" ERROR MESSAGE ISSUE WAS CONFIRMED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR REPAIR." }, { "mdr_text_key": "356759185", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN \"ACTIVATION HAS BEEN INTERRUPTED\" MESSAGE ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR WAS DISPLAYED. THE PATIENT WAS ON THE TABLE UNDER ANESTHESIA WITH PORTS PLACED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ASKED THE CUSTOMER TO PULL THE IESU GENERATOR POWER AND IT POWERED ON WITH A FAULT. THE CUSTOMER DID NOT HAVE ANOTHER DA VINCI SP TOWER TO USE. THE ISI CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT THE SURGEON WAS PLANNING TO RE-SCHEDULE SURGERY AND THE PROCEDURE WAS ABORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }