{ "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": "2955842-2010-00291", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20100702", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20100601", "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", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20100713", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100702", "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": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P8", "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": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20100702", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Death" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Vomiting" ] } ], "distributor_city": "", "date_report": "20100601", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1744642", "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": "15657590", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT CODE HAS BEEN REMOVED PER FDA REQUEST." }, { "mdr_text_key": "15408064", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PT COMPLAINED ABOUT INABILITY FOR LONGER EXERCISING DURING A FOLLOW-UP. IN VIEW OF PHYSICIAN, THE PT FOLLOW-UP DATA REVEALED THAT, DURING RECORDED PT EXERCISE EPISODE, THE DEVICE SWITCHED TO AN INADEQUATE PACING MODE." }, { "mdr_text_key": "21990554", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED BY THE CONSOLE SURGEON, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED, NO SYSTEM MALFUNCTION OCCURRED AND THE SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE. THE CONSOLE SURGEON ADVISED THAT AN AUTOPSY WAS PERFORMED ON (B)(6), 2010, WHICH FOUND THE PRIMARY CAUSE OF DEATH TO BE A GI BLEED CAUSED BY A STRESSED INDUCED ULCER. THE SURGEON REPORTED THAT THE PATIENT HAD BEEN ON A TYPE OF CLEANSING DIET PRIOR TO THE SURGERY THAT MAY HAVE CONTRIBUTED TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE HOSPITAL HAS CONTINUED TO USE THE SYSTEM TO PERFORM SURGERY ON PATIENTS. AS OF (B)(6), 2010, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S DA VINCI S SURGICAL SYSTEM AND NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO ISI." }, { "mdr_text_key": "22122753", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUCCESSFUL DA VINCI S TRANSORAL ROBOTIC SURGERY ON (B)(6), 2010 TO REMOVE A TUMOR AT THE BASE OF THE PATIENT'S TONGUE. THE PHYSICIAN MADE THE DECISION TO KEEP THE PATIENT OVER THE WEEKEND AND ON (B)(6), 2010, THE PATIENT WAS SEEN BY A RESIDENT WHO OBSERVED HIM VOMITING BLOOD. THE PATIENT REQUIRED INTUBATION; HOWEVER, PRIOR TO COMPLETING INTUBATION, THE PATIENT EXPIRED." } ], "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": "07/13/2010" } ] }