{ "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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ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT THE PROCEDURE WAS COMPLEX, AND TOOK MULTIPLE HOURS TO PERFORM. AN INTRA-OPERATIVE ULTRASOUND WAS PERFORMED AND CONFIRMED THAT THE MASS WAS LOCATED DEEP INSIDE OF THE KIDNEY, WHICH REQUIRED EXTENSIVE RECONSTRUCTIVE EFFORTS. ACCORDING TO THE OP REPORT, THERE WAS NO REPORTED MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. NO INTRA-OPERATIVE ADVERSE EVENT WAS REPORTED EITHER. THE PATIENT WAS RE-ADMITTED DUE TO LIVER LACERATION. THE MEDICAL CHARTS FOR THIS HOSPITALIZATION WERE NOT AVAILABLE, BUT IN THE DOCUMENTATION DATED (B)(6) 2012, THIS RE-ADMISSION WAS STATED. ON (B)(6), 2012 VISIT, THE PATIENT WAS REPORTEDLY IMPROVING. ON (B)(6) 2012, THE PATIENT VISITED THE DOCTOR'S OFFICE AND HE CONTINUED TO IMPROVE. THE PATIENT APPEARED WELL WITH NO OBVIOUS SIGNS OF DISTRESS. NO MEDICAL RECORDS SINCE THIS OFFICE VISIT WERE PROVIDED." }, { "mdr_text_key": "17046283", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ON (B)(4) 2013, ISI CONTACTED THE HOSPITAL RISK MANAGER. THE RISK MANAGER INDICATED THAT DUE TO HIPAA REGULATIONS, SHE IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT OR THE REPORTED EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE." } ], "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": "" } ] }