{ "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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INTUITIVE SURGICAL, INC. (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) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED AN INTRA-OPERATIVE COMPLICATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S BLADDER INJURIES IS UNKNOWN." }, { "mdr_text_key": "4028948", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: WHILE PERFORMING THE LAPAROSCOPIC ROBOTIC ASSISTED SACROCOLPOPEXY, THE SURGICAL TEAM NOTICED TWO HOLES IN THE BLADDER. IMMEDIATE REPAIR WAS PERFORMED PER PHYSICIAN." } ], "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": "" } ] }