{ "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": "Injury", "report_number": "2955842-2015-01503", "type_of_report": [ "" ], "product_problem_flag": "N", "date_received": "20151218", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20150616", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20151218", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "836343", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151218", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20151218", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "69", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Headache" ] } ], "distributor_city": "", "date_report": "20151119", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5312363", "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": "33939391", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "FURTHER INVESTIGATION IS BEING COMPLETED TO DETERMINE THE EXACT SOURCE OF THE LOW INTENSITY FOCI. FURTHER INVESTIGATION IS ALSO UNDERWAY TO DETERMINE IF ANY POTENTIAL SOURCES OF METALLIC PARTICULATE THAT MAY BE INTRODUCED DURING MITRAL VALVE REPAIR. THESE POTENTIAL SOURCES INCLUDE DA VINCI INSTRUMENTATION, NEEDLES AND ABLATION PROBES. THERE WERE NO REPORTED FAILURES OF THE DA VINCI INSTRUMENTS OR SYSTEM FROM THE PROCEDURE THAT CAN BE ATTRIBUTED TO THE PATIENT REPORTED SYMPTOMS OR SUBSEQUENT MRI RESULTS. THE PATIENT DOES NOT CURRENTLY HAVE ANY SYMPTOMS AND THE REPORTED MIGRAIN HEADACHES HAVE CEASED. PER THE SURGEON THAT PERFORMED THE DA VINCI ASSISTED MITRAL VALVE PROCEDURE, THERE IS NO PATHOLOGY AVAILABLE TO DETERMINE WHETHER THE IMAGE ARTIFACTS ARE RELATED TO MICRO-HEMORRHAGES OR METALLIC EMBOLI. AS PART OF THEIR INVESTIGATION, THE HOSPITAL IS IN THE PROCESS OF INQUIRING FROM MANUFACTURERS OF ALL POTENTIAL METALLIC PARTICULATE SOURCES IF THEY HAVE KNOWLEDGE THAT THEIR EQUIPMENT CAN PRODUCE METALLIC PARTICULATE OF SUCH A PROBLEM. THESE MANUFACTURERS INCLUDE IRRIGATORS, OXYGENATORS, AND ENDO-BALLOON MAKERS. A FOLLOW UP MDR WILL BE SUBMITTED WITH ADDITIONAL INFORMATION AND TEST RESULTS ONCE COMPLETED." }, { "mdr_text_key": "33939392", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS POST A SUCCESSFUL DA VINCI-ASSISTED MITRAL VALVE PROCEDURE, THE PATIENT PRESENTED WITH MIGRAINE HEADACHES. THE PATIENT'S MITRAL VALVE PROCEDURE WAS PERFORMED TO TREAT SEVERE MITRAL REGURGITATION WITH MILD LEFT VENTRICULAR DYSFUNCTION AND DILATED TRICUSPID ANNULUS. THE MITRAL VALVE REPAIR WAS PERFORMED UTILIZING A 35 FLEXIBLE ANNULOPLASTY BAND AND SUTURE CLOSURE OF THE LEFT ATRIAL APPENDAGE WITH TRICUSPID VALVE REPAIR USING A 25 ANNULOPLASTY BAND WHICH WAS ALSO FLEXIBLE IN NATURE. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE OR DURING POST-OPERATIVE CARE. A SERIES OF MEDICAL IMAGES WERE COMPLETED IN RESPONSE TO THE PATIENT'S REPORTED MIGRAINE HEADACHES. X-RAY AND CT IMAGES WERE NEGATIVE. AN MRI OF THE BRAIN SHOWED SMALL FOCI OF LOW SMALL SIGNAL INTENSITY. ACCORDING TO THE RADIOLOGY REPORT, SUCH FOCI ARE MOST COMMONLY DUE TO A MICROHEMORRHAGE, CALCIFICATIONS, CAVERNOMAS OR CAPILLARY TELANGIECTASIA. METALLIC MICROEMBOLI ARE EXCEPTIONALLY RARE CAUSES OF SUCH A SIGNAL." } ], "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": "" } ] }