{ "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": "2955842-2013-00608", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130225", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20100929", "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": "20130225", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "80514", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130225", "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 A51P8", "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": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20130225", "sequence_number_treatment": [ "DAVINCI S SYSTEM, ESU, INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20130124", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2975656", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130124", "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": "16913180", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, A PATIENT CONTACTED ISI EMPLOYEE TO REPORT THAT ON (B)(6) 2010, HE HAD A MITRAL VALVE REPAIR SURGERY PERFORMED WITH A DA VINCI S SURGICAL ROBOT SYSTEM AT (B)(6). ACCORDING TO THE INFORMATION STATEMENT PROVIDED BY THE PATIENT, IT WAS INDICATED THAT HE DID NOT FEEL WELL AFTER THE SURGERY, AND HE HAD TO RETURN FOR A SECOND OPEN SURGERY TO REPAIR THREE PROBLEMS, WHICH HE WAS TOLD WERE A RESULT OF THE FIRST DA VINCI PROCEDURE. REPORTEDLY, THE PATIENT WAS INFORMED BY THE SECOND SURGEON WHO PERFORMED THE CORRECTIVE SURGERY THAT THE FIRST DA VINCI ROBOTIC SURGERY PROCEDURE TOOK 90 MINUTES LONGER THAN IT WAS ORIGINALLY PLANNED, AND THAT THE PROBLEMS HE SUFFERED WERE DUE TO ERRORS MADE BY THE FIRST SURGEON. THE PATIENT INDICATED THAT HE STILL HAS ATRIAL FIBRILLATION ISSUES, AND HE IS NOW WEARING A PACEMAKER." }, { "mdr_text_key": "16947460", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, ISI RECEIVED THE MEDICAL RECORDS FROM THE PATIENT. ACCORDING TO THE MEDICAL RECORDS, ON (B)(6) 2010, THE PATIENT UNDERWENT A DA VINCI MITRAL VALVE REPAIR CONSISTING OF 2 NEO CHORDS 4-0 GORE-TEX SUTURE, REDUCTION ANNULOPLASTY USING A FLEXIBLE ANNULAR RING AND A CRYOMAZE PROCEDURE. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT TOLERATED THE PROCEDURE WELL, WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION IN NORMAL SINUS RHYTHM. ON (B)(6) 2011, THE PATIENT HAD A SEVERE SYMPTOMATIC RECURRENT MITRAL REGURGITATION PROCEDURE PERFORMED. ACCORDING TO THE MEDICAL RECORDS, A RADICAL RECONSTRUCTION REDO MITRAL VALVE REPAIR, RESECTION OF P2 RUPTURE CHORD, REMOVAL OF A PREVIOUS ANNULOPLASTY RING, AND PLACEMENT OF ANOTHER ANNULOPLASTY RING WAS PERFORMED. PER MEDICAL RECORDS, THE PATIENT WAS THEN TRANSFERRED TO THE ICU IN STABLE CONDITION. A REVIEW OF THE SYSTEM LOGS SHOWS NO SYSTEM MALFUNCTION OCCURRING DURING THE PROCEDURE PERFORMED ON (B)(6) 2010. A FOLLOW-UP MDR WILL BE SUBMITTED IF A DEVICE IF ADDITIONAL INFORMATION IS RECEIVED. WE SUBSEQUENTLY LEARNED THAT THE SURGEON WHO PERFORMED THE INITIAL PROCEDURE IS DECEASED AS OF (B)(6) 2012." } ], "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": "" } ] }