{ "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 NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION(S) EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED 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) 2009. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT'S ATTORNEY ALLEGED THAT THE PATIENT SUFFERED GRIEVOUS AND PERMANENT PERSONAL INJURIES AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "11171880", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) WAS ABLE TO CONTACT A RISK MANAGER FROM THE SITE. THE RISK MANAGER STATED THAT SHE COULD NOT PROVIDE ANY INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, AN ADDITIONAL FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "17839708", "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) 2009. THE LEGAL COMPLAINT ALLEGED THAT THE DA VINCI SURGICAL SYSTEM MALFUNCTIONED AND THE PATIENT SUFFERED GRIEVOUS AND PERMANENT PERSONAL INJURIES, PAIN, SUFFERING AND LOSS OF ENJOYMENT OF LIFE, AGGRAVATION, EXACERBATION AND WORSENING OF PRE-EXISTING CONDITIONS, AND INCURRED PECUNIARY DAMAGES, MEDICAL, HOSPITAL, REHABILITATIVE AND OTHER EXPENSES, AND DIMINUTION OF CURRENT AND FUTURE EARNING CAPACITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME." } ], "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": "09/26/2013" } ] }