{ "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 FOR THE OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON INDICATED THAT A PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE AND HER BLADDER WAS INJURED. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S BLADDER INJURY IS UNKNOWN." }, { "mdr_text_key": "18460396", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 08/22/2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SITE'S RISK MANAGER INDICATED THAT SHE SPOKE TO THE SURGEON INVOLVED WITH THIS COMPLAINT. ACCORDING TO THE RISK MANAGER, THE SURGEON STATED THERE WERE NO ISSUES WITH THE DA VINCI EQUIPMENT. NO OTHER INFORMATION WAS PROVIDED BY THE RISK MANAGER." }, { "mdr_text_key": "21968506", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT'S BLADDER WAS INJURED. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT SHE WAS INFORMED OF THE EVENT BY THE SURGEON IN PASSING THROUGH A HALLWAY. NO OTHER INFORMATION WAS PROVIDED." } ], "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": "09/12/2014" } ] }