{ "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) CONTACTED THE RISK MANAGEMENT DEPARTMENT AND DIRECTOR OF INSURANCE OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. ISI HAS REVIEWED THE SYSTEM LOGS WITH A DATE OF (B)(6) 2010, THE DATE THE REPORTED DA VINCI SI HYSTERECTOMY PROCEDURE WAS PERFORMED. BASED ON THE REVIEW OF THE SYSTEM LOGS, THERE IS NO EVIDENCE THAT A SYSTEM ERROR OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "10848748", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL INC. (ISI) CONTACTED THE RISK MANAGEMENT DEPARTMENT AND DIRECTOR OF INSURANCE OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. ISI HAS REVIEWED THE SYSTEM LOGS WITH A DATE OF (B)(6) 2010, THE DATE THE REPORTED DA VINCI SI HYSTERECTOMY PROCEDURE WAS PERFORMED. BASED ON THE REVIEW OF THE SYSTEM LOGS, THERE IS NO EVIDENCE THAT A SYSTEM ERROR OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "3507570", "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 WITH THE FOLLOWING ALLEGATION RELATED TO A DA VINCI SI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2010: THE LEGAL COMPLAINT ALLEGED THAT ON (B)(6) 2010, THE DA VINCI SURGICAL SYSTEM MALFUNCTIONED, AND AS A RESULT OF THE REPORTED ISSUE, THE PATIENT ALLEGEDLY 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 LOSS OF ABILITY TO WORK." } ], "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": "" } ] }