{ "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": "2955842-2013-01869", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20130529", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120202", "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": "20130529", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "235064", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130529", "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 A6.0P3", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20130529", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Life Threatening" ], "patient_age": "49 YR", "patient_sex": "", "patient_weight": "95", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20130502", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3133820", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130904", "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": "11262699", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED CDS CONTAINING THE PATIENT'S HISTORY OF IMAGING STUDIES AND ADDITIONAL MEDICAL RECORDS. ISI'S REVIEW OF AN X-RAY PERFORMED ON (B)(6) 2012 FOUND EVIDENCE SUGGESTING THAT THE PATIENT UNDERWENT AN OPEN HEART SURGERY AND PREVIOUS MITRAL VALVE REPLACEMENT. ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY, ON (B)(6) 2012 THE PATIENT UNDERWENT A RE-OPERATIVE MITRAL VALVE REPLACEMENT, CORONARY ARTERY BYPASS GRAFTING TIMES 1 WITH A REVERSE SAPHENOUS VEIN GRAFT TO RAMUS INTERMEDIUS CORONARY ARTERY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY DUE TO MITRAL VALVE REGURGITATION, STATUS POST MITRAL VALVE REPAIR, SYSTOLIC AND DIASTOLIC HEART FAILURE AND ATRIAL FIBRILLATION. IT WAS ALSO STATED IN THE PATIENT'S DISCHARGE SUMMARY THAT THE PATIENT'S POST-OPERATIVE COURSE AFTER THE DA VINCI MITRAL VALVE REPAIR PROCEDURE PERFORMED ON (B)(6) 2012 WAS COMPLICATED. THE PATIENT WAS FOUND TO HAVE A DECREASED LEFT VENTRICULAR SYSTOLIC DYSFUNCTION WITH AN EJECTION FRACTION OF APPROXIMATELY 20 PERCENT AND PERSISTENT MITRAL VALVE REGURGITATION. THE PATIENT DURING PRE-OPERATIVE CATHETERIZATION WAS NOTED TO HAVE A SUBSTANTIALLY LARGE OCCLUDED RAMUS ARTERY. THE PATIENT DEVELOPED CARDIOGENIC SHOCK DUE TO INFERIOR/RV INFARCTION. THE PATIENT WAS EVALUATED IN MAY 2012 AND WAS ADVISED TO UNDERGO MITRAL VALVE REPLACEMENT. AS PER THE DISCHARGE SUMMARY, A FOLLOW-UP EKG ON (B)(6) 2012 SHOWED LVEF 40-45 PERCENT, MODERATE-SEVERE MR, NORMAL RV SIZE/FUNCTION. ACCORDING TO THE INFORMATION IN THE DISCHARGE SUMMARY, FOLLOWING THE PATIENT'S SURGICAL PROCEDURE ON (B)(6) 2012, THE PATIENT REQUIRED A MODERATE AMOUNT OF INOTROPIC SUPPORT AND VASOPRESSOR SUPPORT TO WEAN OFF CARDIOPULMONARY BYPASS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN GUARDED CONDITION. REPORTEDLY, AFTER A COUPLE OF DAYS THE PATIENT WAS SLOWLY WEANED OFF INOTROPIC SUPPORT AND WAS EXTUBATED THE DAY OF SURGERY AND CONTINUED TO MAKE VERY GOOD PROGRESS. ON POST-OP DAY 4 THE PATIENT WAS TRANSFERRED TO TELEMETRY, WHERE SHE CONTINUED TO MAKE VERY GOOD PROGRESS. THE PATIENT WAS STARTED ON AN ANTICOAGULATION REGIMEN, AND WAS DISCHARGED HOME ON (B)(6) 2012 IN VERY STABLE CONDITION. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OP DAY NUMBER 6 COMPLAINING OF PALPITATIONS AND SHORTNESS OF BREATH. DURING A FOLLOW-UP VISIT ON (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE SLIGHTLY MORE ENERGY AND COMPLAINED OF CONTINUED LOWER EXTREMITY EDEMA THAT CAUSED INCISIONAL PAIN. BASED ON THE INFORMATION PROVIDED IN THE PATIENT'S MEDICAL RECORDS THE PATIENT CONTINUED TO IMPROVE POST-OPERATIVELY." }, { "mdr_text_key": "19469041", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT AND CLAIMS DEPARTMENT. THE RISK MANAGER AND THE CLAIMS DEPARTMENT INDICATED THAT THEY ARE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT SINCE THE REPORTED EVENT IS IN LITIGATION. DUE TO HIPPA REGULATIONS, THE HOSPITAL IS UNABLE TO RELEASE THE PATIENT'S MEDICAL RECORDS WITHOUT A SIGNED RELEASE FORM FROM THE PATIENT. BASED ON THE LIMITED INFORMATION PROVIDED REGARDING THE REPORTED EVENT, AT THIS TIME THE ROOT CAUSE OF THE INJURIES SUSTAINED BY THE PATIENT HAS NOT BEEN DETERMINED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "11014508", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL RECEIVED COPIES OF THE PATIENT'S MEDICAL RECORDS. THE PATIENT'S OPERATIVE REPORT (OP) AND ADMISSIONS RECORDS WERE PROVIDED. THE PATIENT'S OP REPORT INDICATED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI MITRAL VALVE REPAIR (TRIANGULAR RESECTION OF THE P2 SEGMENT OF THE POSTERIOR LEAFLET WITH ARTIFICIAL GORE-TEX CHORDAE TO THE A3 SEGMENT OF THE ANTERIOR LEAFLET AND POSTERIOR ANNULOPLASTY BAND) AND MAZE PROCEDURE CONSISTING OF PULMONARY VEIN ISOLATION WITH OVER SEWING OF THE LEFT ATRIAL APPENDAGE. THE PATIENT HAD A KNOWN HISTORY OF MITRAL VALVE REGURGITATION WHO PRESENTED WITH THE ONSET OF ATRIAL FIBRILLATION OVER THE PAST TWO YEARS AND MILD PULMONARY HYPERTENSION. THE PATIENT COMPLAINED OF PALPITATIONS AND SHORTNESS OF BREATH. SERIAL ECHOCARDIOGRAMS DEMONSTRATED THAT THE PATIENT HAD SIGNIFICANT MITRAL REGURGITATION WITH LEFT VENTRICULAR DILATION. BASED ON THE INFORMATION INDICATED IN THE PATIENT'S OP REPORT, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE OPEN PROCEDURE WELL AND WAS WEANED FROM BYPASS WITHOUT ANY COMPLICATIONS. DURING PLACEMENT OF THE PATIENT'S DRESSINGS THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (V-FIB) ARREST X2 WHICH REQUIRED A BRIEF PERIOD OF CHEST COMPRESSIONS AND DEFIBRILLATIONS X2. A REPEAT ECHOCARDIOGRAM SHOWED TRIVIAL MITRAL REGURGITATION AND PRESERVED LEFT VENTRICLE AND RIGHT VENTRICLE FUNCTION. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. SHORTLY AFTER ARRIVAL INTO THE ICU, THE PATIENT EXPERIENCED A RECURRENT V-FIB REQUIRING 5 MINUTES OF COMPRESSIONS AND 1 DEFIBRILLATION. AN ECHOCARDIOGRAM PERFORMED SHOWED THAT THE PATIENT HAD POOR RIGHT VENTRICULAR FUNCTION. CARDIAC ENZYMES WERE DRAWN AND WERE NOTED TO BE ELEVATED AND THE PATIENT HAD INFERIOR EKG CHANGES THAT WERE CONSISTENT WITH RIGHT VENTRICULAR INFARCTION/INFERIOR MYOCARDIAL INFARCTION. INOTROPIC DRIPS WERE ADMINISTERED TO THE PATIENT OVER A NUMBER OF DAYS. THE PATIENT WAS SUBSEQUENTLY WEANED AND WAS EXTUBATED ON THE 4TH DAY POSTOPERATIVELY. THE PATIENT CONTINUED TO DO WELL AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT'S MEDICAL RECORDS SHOWED THAT FROM FEBRUARY (B)(6) 2012 THROUGH (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM MANY TIMES COMPLAINING OF HEART PALPITATIONS, ANXIOUSNESS SURROUNDING HER CARDIAC ARREST AND LEFT ARM AND BACK PAIN. PER THE PATIENT'S MEDICAL RECORDS, THE PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT PROCEDURE ON (B)(6) 2012. THE PATIENT'S OPERATIVE REPORT WAS NOT PROVIDED FOR THIS SURGICAL PROCEDURE." }, { "mdr_text_key": "19194995", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL COMPLAINT. THE LEGAL COMPLAINT ALLEGES THAT DURING A DA VINCI SI MITRAL VALVE REPAIR PROCEDURE, THE PATIENT'S CORONARY ARTERY WAS INADVERTENTLY OBSTRUCTED, CAUSING SEVERE PERMANENT HEART DAMAGE. THE LEGAL COMPLAINT ALLEGES THAT THE PATIENT EXPERIENCED CARDIAC ARREST THREE TIMES." } ], "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": "08/21/2013;10/04/2013" } ] }