{ "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": "2955842-2016-00480", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20160701", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120827", "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": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160701", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "420258", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160701", "brand_name": "DA VINCI SI 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": "IS3000", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20160701", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adult Respiratory Distress Syndrome", "Death", "Mitral Valve Stenosis", "Tissue Damage", "Adult Respiratory Distress Syndrome", "Death", "Mitral Valve Stenosis", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20160606", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5765241", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160606", "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": "48655774", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2012. BASED ON THE AVAILABLE SYSTEM LOG INFORMATION, NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. EACH REUSABLE (MULTI-USE) INSTRUMENT USED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WERE USED IN SUBSEQUENT SURGICAL PROCEDURES WITHOUT ANY REPORTED ISSUES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI-ASSISTED MITRAL VALVE REPLACEMENT PROCEDURE, THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE SURGEON INJURED THE DOME OF THE PATIENT'S LEFT ATRIUM AND THE PATIENT SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE ARE UNKNOWN." }, { "mdr_text_key": "48655775", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2012 FOR A HISTORY OF ATRIAL FIBRILLATION AND MITRAL STENOSIS. ISI WAS NOT PROVIDED WITH THE DA VINCI OPERATIVE REPORT. BASED ON THE LEGAL DOCUMENTS PROVIDED BY THE PLAINTIFF'S ATTORNEY, THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY OCCURRED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE PLAINTIFF'S ATTORNEY CLAIMS THAT DURING THE SURGICAL PROCEDURE, THE SURGEON ALLEGEDLY CAUSED A TEAR TO THE DOME OF THE LEFT ATRIUM, CAUSING SEVERE PERMANENT LUNG DAMAGE AND DEATH ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENTS PROVIDED, THE PATIENT PASSED AWAY FROM ADULT RESPIRATORY DISTRESS SYNDROME DUE TO MITRAL STENOSIS. THE PLAINTIFF'S ATTORNEY ALSO ALLEGES THAT THE SURGEON FAILED TO CONVERT TO OPEN SURGERY AFTER HE CAUSED THE TEAR TO THE ATRIUM. NO FURTHER INFORMATION WAS PROVIDED." } ], "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": "" } ] }