{ "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) CLINICAL SURVEY ON XI / X MONOPOLAR INSTRUMENTS, A CUSTOMER RECALLED AN EVENT REGARDING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT WAS CONVERTED TO OPEN SURGERY DUE TO A MALFUNCTION AND / OR BREAKAGE OF AN UNSPECIFIED DA VINCI MONOPOLAR INSTRUMENT. THE CUSTOMER DID NOT SPECIFY THE NUMBER OF CONVERSIONS FROM DA VINCI SURGICAL PROCEDURE TO OPEN SURGERY FOR MALFUNCTION / BREAKAGE. THE CUSTOMER WHO RESPONDED TO THE SURVEY WAS ANONYMOUS. THE CUSTOMER DID NOT COMPLETE THE ENTIRE SURVEY LEADING TO INCOMPLETE INFORMATION." }, { "mdr_text_key": "321264474", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE CANNOT BE DETERMINED. THERE IS INSUFFICIENT INFORMATION PROVIDED IN REGARDS TO THE FOLLOWING: INSTRUMENT NAME AND PART / LOT#, EVENT DATE, SURGERY NAME, TYPE OF PROCEDURE, AND SURGEON NAME. 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