{ "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": "2955842-2010-00141", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20100409", "manufacturer_address_2": "", "pma_pmn_number": "K070684", "date_of_event": "20100318", "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": "20100409", "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 A5.1P.8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20100409", "sequence_number_treatment": [ "DA VINCI S SYSTEM, INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "77 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Disseminated Intravascular Coagulation (DIC)", "Liver Damage/Dysfunction", "Renal Failure" ] } ], "distributor_city": "", "date_report": "20100320", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1655250", "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": "1576321", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A DA VINCI S COX CRYO-MAZE ATRIAL FIBRILLATION PROCEDURE, THE PATIENT SUFFERED FROM HEPATORENAL FAILURE AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). IT WAS REPORTED THAT THE PATIENT EXPIRED TWO DAYS AFTER THE PROCEDURE. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM." }, { "mdr_text_key": "21786421", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT AN ALLIANCE INFLATION HANDLE WAS INVOLVED IN A DILATATION PROCEDURE (PATIENT AGE, GENDER, WEIGHT, ID AND EVENT DATE ARE UNKNOWN) ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE ALLIANCE HANDLE IS UNABLE TO PRODUCE ENOUGH PRESSURE TO EITHER INFLATE OR DEFLATE THE CRE BALLOON. THE CUSTOMER HAD TO SET THE HANDLE TO NEUTRAL AND MANUALLY INFLATE AND DEFLATE THE BALLOON BUT PUSHING AND PULLING THE ALLIANCE SYRINGE FORWARDS AND BACKWARDS. THE PROCEDURE WAS COMPLETED THIS WAY WITH NO PATIENT COMPLICATIONS. THE PATIENTS CONDITION HAS BEEN REPORTED AS GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "8490145", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "NO MALFUNCTIONS OF THE DA VINCI S SURGICAL SYSTEM WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE AND THE HOSPITAL HAS CONTINUED TO USE THE SYSTEM TO PERFORM SURGERY ON PATIENTS. AS OF APRIL 8, 2010, NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO ISI." }, { "mdr_text_key": "21745172", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT CODE HAS BEEN REMOVED PER FDA REQUEST." } ], "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" } ] }