{ "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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THE LEGAL DOCUMENT ALLEGES THAT THE 64 YEAR OLD MAN SUSTAINED SEVERE INTERNAL INJURIES, DAMAGE TO OTHER ORGANS, CONTINUING PAIN AND UNDERWENT ADDITIONAL SURGERIES TO ADDRESS THE SEVERE INTERNAL DAMAGES. NO OTHER DETAILS WERE PROVIDED REGARDING THE PATIENT'S INJURIES. THE LEGAL DOCUMENT NOTED THAT MONOPOLAR CURRENT WAS USED DURING THE DA VINCI PROSTATECTOMY PROCEDURE; HOWEVER, THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES. THE PATIENT DID NOT BELIEVE THE CAUSE OF HIS INJURIES WERE RELATED TO THE DA VINCI SYSTEM UNTIL (B)(6) 2013. THE PROVIDED INFORMATION DID NOT INCLUDE THE HOSPITAL NAME AND THE DETAILS OF THE DA VINCI SYSTEM INVOLVED WITH THE REPORTED EVENT." }, { "mdr_text_key": "11142056", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. 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