{ "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) REVIEWED THE ERROR LOGS AND FOUND THAT NO ISSUES OCCURRED ON SUBSEQUENT CASES. NO SITE VISIT WAS CONDUCTED. THE SYSTEM REPORTEDLY WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. A REVIEW OF THE INSTRUMENT LOGS REVEALS THAT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED WITH THE REPORTED EVENT HAS BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY COMPLAINTS REPORTED AGAINST THE MCS INSTRUMENT. ISI HAS REQUESTED FOR RETURN OF THE MCS TIP COVER ACCESSORY FOR FAILURE ANALYSIS EVALUATION. ISI HAS NOT RECEIVED THE MCS TIP COVER ACCESSORY. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED." }, { "mdr_text_key": "324865184", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, A \"SHEATH\" FELL INSIDE THE PATIENT AND WAS RECOVERED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF ANY PATIENT HARM OR INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE SURGEON TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN RECEIVED." } ], "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": "" } ] }