{ "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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NO OTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11784417", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS AND SUBSEQUENT DEMISE OF THE PATIENT. ON (B)(4) 2014, ISI CONTACTED THE SITE'S RISK MANAGER TO VERIFY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE RISK MANAGER, THE SITE IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI GASTROSTOMY PROCEDURE AND SUBSEQUENTLY EXPIRED. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. 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." } ], "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": "" } ] }