{ "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": "2955842-2015-01504", "type_of_report": [ "" ], "product_problem_flag": "N", "date_received": "20151218", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20150615", "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": [ "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": "836317", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "63 YR", "patient_sex": "", "patient_weight": "83", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dizziness" ] } ], "distributor_city": "", "date_report": "20151123", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5312369", "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": "33939243", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "FURTHER INVESTIGATION IS BEING COMPLETED TO DETERMINE THE EXACT SOURCE OF THE ARTIFACTS. FURTHER INVESTIGATION IS ALSO UNDERWAY TO DETERMINE IF ANY POTENTIAL SOURCES OF METALLIC PARTICULATE 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 DIZZINESS HAS 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. THESE POTENTIAL SOURCES INCLUDE IRRIGATORS, OXYGENATORS, ENDO-BALLOON MAKERS, DA VINCI INSTRUMENTATION, NEEDLES AND ABLATION PROBES. A FOLLOW UP MDR WILL BE SUBMITTED WITH ADDITIONAL INFORMATION AND TEST RESULTS ONCE COMPLETED." }, { "mdr_text_key": "33939244", "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 DIZZINESS. THE PATIENT'S MITRAL VALVE PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION. THE MITRAL VALVE REPAIR WAS PERFORMED UTILIZING A 36 SEMI-RIGID ATS ANNULOPLASTY RING WITH SUTURE CLOSURE OF THE LEFT ATRIAL APPENDAGE AND CRYOBLATION OF THE LEFT ATRIUM. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE OR DURING POST-OPERATIVE CARE. A SERIES OF MEDICAL IMAGES WERE COMPLETED IN RESPONSE TO THE REPORTED DIZZINESS. AN X-RAY AND CT IMAGES OF THE BRAIN WERE NEGATIVE. MRI BRAIN SHOWED SMALL BLOOMING HYPOINTENSE FOCI. ACCORDING TO THE RADIOLOGY REPORT, THE RADIOLOGIST'S IMPRESSION WAS THAT THESE WERE FOCI OF HEMOSIDERIN WITH DIFFERENTIAL CONSIDERATIONS INCLUDING MILD CEREBRAL AMYLOID ANGIOPATHY, MULTIPLE CAVERNOMAS, OR PRIOR MICROHEMORRHAGES. UPON A SECOND REVIEW OF THE MRI, AFTER THE RADIOLOGIST RECEIVED THE ADDITIONAL PATIENT HISTORY OF MITRAL VALVE SURGERY, THE FOCI WERE DESCRIBED AS SUSPICIOUS FOR METALLIC MICROEMBOLI. CLINICAL LITERATURE SEARCH HAS FOUND THAT BOTH MICROHEMORRHAGE AND METALLIC EMBOLI CAN CAUSE THE BLOOMING HYPOINTENSE FOCI AS IDENTIFIED IN THE PATIENT'S MRI." } ], "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": "" } ] }