{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2955842-2013-05719", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131213", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131114", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131213", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "653229", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131213", "brand_name": "DA VINCI SI SURGICAL PROCEDURE", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS 3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "ME", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20131213", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20131114", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3518625", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131114", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "4104882", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AT AN UNSPECIFIED TIME, EITHER DURING OR AFTER A DA VINCI GASTRIC BYPASS PROCEDURE, THE PATIENT EXPIRED. THE SURGEON INDICATED THAT THIS CASE WAS REVIEWED BY A COMMITTEE OF PEERS, ADMINISTRATORS, THE MEDICAL AND LEGAL DEPARTMENT AND IT WAS CONFIRMED THAT THE PATIENT'S DEATH WAS NOT RELATED TO A ROBOTIC COMPLICATION NOR WAS IT SURGICAL MISADVENTURE. NO FURTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11303659", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DUE TO THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S DEATH AS OF THE DATE OF THIS REPORT. ISI HAS CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT AND THE SURGEON TO GATHER ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE SURGEON WHOM PERFORMED THE GASTRIC BYPASS PROCEDURE, STATED THAT THE CAUSE OF DEATH WAS DUE TO A GASTRIC LEAK AND SHE REITERATED THAT THE DA VINCI PROCEDURE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE. NO FURTHER INFORMATION WAS PROVIDED BY THE SURGEON. 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. THERE IS NO EVIDENCE AT THIS TIME THAT THE DA VINCI SYSTEM MALFUNCTIONED DURING THE GASTRIC BYPASS PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S DEATH. AS STATED ABOVE, THE SURGEON INDICATED THAT THE PATIENT'S DEATH WAS CAUSED BY A GASTRIC LEAK AND DENIED THAT THE DA VINCI SYSTEM CONTRIBUTED TO THE DEATH." } ], "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": "" } ] }