{ "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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ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) REGULATORY POST-MARKET SURVEILLANCE ANALYST. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "329845093", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE DISTAL SHAFT OFFSET ITSELF AND CAUSED PARTS OF AN INSTRUMENT TO FALL INTO THE PATIENT'S ABDOMEN. THE PARTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. 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