{ "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": "2955842-2010-00452", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20101022", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20100913", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Invalid data" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20101105", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20101022", "brand_name": "DA VINCI S SURGICAL SYSTEM", "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": "IS2000", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20101022", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Necrosis", "Occlusion" ] } ], "distributor_city": "", "date_report": "20100922", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1880162", "removal_correction_number": "", "number_devices_in_event": "", "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": "1470330", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI S GASTRECTOMY PROCEDURE PERFORMED ON (B)(6) 2010, THE SURGEON NOTICED THAT THE PATIENT'S PANCREAS WAS DAMAGED. THE SURGEON REPAIRED THE DAMAGED PANCREAS AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO SYSTEM MALFUNCTIONS. POST-OPERATIVELY, THERE WAS OCCLUSION OF THE PATIENT'S SUPERIOR MESENTERIC ARTERY AND NECROSIS OF THE COLON OCCURRED. ON (B)(6) 2010, THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE TO RESECT HIS BOWEL. NECROTIZING FASCIITIS OCCURRED AFTER THE SURGERY AND THE PATIENT PASSED AWAY ON (B)(6) 2010, DUE TO MULTI-ORGAN FAILURE." }, { "mdr_text_key": "19427438", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "8921600", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE HOSPITAL HAS INDICATED THAT THE PATIENT DEATH WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED AND NO SYSTEM MALFUNCTIONS OCCURRED. AS OF OCTOBER 19, 2010, NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO INTUITIVE SURGICAL. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "19272518", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI S GASTRECTOMY PROCEDURE PERFORMED ON (B)(6) 2010, THE SURGEON NOTICED THAT THE PATIENT'S PANCREAS WAS DAMAGED. THE SURGEON REPAIRED THE DAMAGED PANCREAS AND A DRAIN WAS PLACED AROUND THE PANCREAS. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO SYSTEM MALFUNCTIONS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH PANCREATIC FISTULA AND HIS BLOOD HEPATIC ENZYME LEVEL WAS HIGH. ON THE EVENING OF (B)(6) 2010, A CT SCAN WAS PERFORMED AND IT WAS DISCOVERED THAT THE UPPER INTESTINAL MEMBRANE ARTERY WAS BLOCKED AND BOWEL ISCHEMIA WAS FOUND AROUND THE PERFUSED AREA OF THE UPPER INTESTINAL MEMBRANE ARTERY. THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE AND A DRAIN WAS AGAIN PLACED AROUND THE PANCREAS. A GASTROSTOMY TUBE AND DUODENAL FISTULA TUBE WERE ALSO PLACED. WHILE IN ICU, THE PATIENT'S METABOLIC ACIDOSIS DID NOT IMPROVE AND HIS BOWEL COLOR WAS GETTING WORSE. ON (B)(6) 2010, THE PATIENT'S ABDOMEN WAS RE-OPENED AND HIS 4M SMALL BOWEL AND RIGHT COLON WERE RESECTED. NECROTIZING FASCIITIS OCCURRED AFTER THE SURGERY. THE BLOOD POISONING COULD NOT BE CONTROLLED AND THE PATIENT PASSED AWAY ON (B)(6) 2010." } ], "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": "11/05/2010" } ] }