{ "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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(B)(6) THE SURGEON WHO HAD PROVIDED THE INITIAL PATIENT CARE. ON (B)(6) 2013, DR. (B)(6) INFORMED HE WOULD SEEK LEGAL ADVICE PRIOR TO OPENING DIALOGUE FOR THIS COMPLAINT. A REVIEW OF SYSTEM LOGS FOR THE DA VINCI S SYSTEM USED IN THE CASE ON THE EVENT DATE ((B)(6) 2010) SHOWED NO ERRORS DURING THE PROCEDURE. THE ROOT CAUSE OF THE REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA." }, { "mdr_text_key": "17973595", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED A LEGAL SUMMONS ALLEGING A PATIENT WAS BURNED AND THE SYSTEM TORE TISSUES OF THE PATIENT'S RECTUM, CAUSING A FISTULA WHICH REQUIRED SUBSEQUENT HOSPITALIZATIONS AND MULTIPLE SURGICAL PROCEDURES. IT IS ALLEGED THAT THE PATIENT REMAINS INJURED TODAY AS A RESULT. IT IS ALLEGED THAT THE PATIENT IS PERMANENTLY AND SERIOUSLY INJURED. 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