{ "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) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2010. A REVIEW OF THE SYSTEM LOGS REVEALED THAT NO SYSTEM ERRORS OCCURRED DURING REPORTED SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT CLAIMED THAT THE DA VINCI S SURGICAL SYSTEM MALFUNCTIONED AND THE PATIENT SUSTAINED SEVERE AND PERMANENT INJURIES. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE DA VINCI S SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURIES." }, { "mdr_text_key": "16549661", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL COMPLAINT ALLEGED THAT THE DA VINCI SI SURGICAL SYSTEM MALFUNCTIONED AND THE PATIENT SUSTAINED SEVERE, SERIOUS, AND PERMANENT INJURIES. IN ADDITION, THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUFFERED PERMANENT INJURIES, SEVERE INCAPACITIES AND MENTAL ANGUISH." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }