{ "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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THERE IS NO ALLEGATION AT THIS TIME THAT A SPECIFIC INSTRUMENT OR ACCESSORY MANUFACTURED BY INTUITIVE SURGICAL, INC. (ISI) CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THE SYSTEM LOGS REVEAL THAT ALL OF THE INSTRUMENTS USED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WERE USED IN SUBSEQUENT SURGICAL PROCEDURES WITH NO REPORTED ISSUES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SITE'S RISK MANAGEMENT DEPARTMENT CLAIMED THAT A POST-OPERATIVE MRI OF THE PATIENT'S BRAIN REVEALED HEMORRHAGES. 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