{ "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": "2955842-2013-01612", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130510", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110107", "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": "20130513", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "205377", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130510", "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": "0", "model_number": "IS3000 A60.P6", "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": [ "Unintended System Motion", "Increase in Pressure", "Device Operates Differently Than Expected" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20130510", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "51 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Emotional Changes", "Fatigue", "Hemorrhage/Blood Loss/Bleeding", "Laceration(s)", "Pain", "Injury" ] } ], "distributor_city": "", "date_report": "20121219", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3107770", "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": "10763520", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. ISI HAS REVIEWED THE OPERATIVE/PROCEDURE REPORT OF THE PATIENT. BASED ON THE REVIEW OF THE OPERATIVE REPORT, THERE IS NO EVIDENCE THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED, OR CAUSED OR CONTRIBUTED TO THE PATIENT'S ALLEGED INJURIES. THE OPERATIVE REPORT INDICATED THAT THE PATIENT'S CHEST WAS APPROACHED WITH THE DA VINCI SYSTEM WHERE THE DIAPHRAGM WAS VERY ELEVATED DESPITE SEVERAL TRACTION SUTURES THAT WERE PLACED. THE OPERATIVE REPORT INDICATED THAT THE SURGICAL STAFF DID NOT HAVE ENOUGH ROOM FOR THE ARMS TO WORK SO THE SURGEON DECIDED TO ABORT THIS PROCEDURE AND THEN EXTEND THE WORKING PORT TO MAKE A LATERAL APPROACH FOR THE OPERATION. AT THE COMPLETION OF THE SURGERY, THE OPERATIVE REPORT INDICATED THAT THE PATIENT RETURNED TO THE CORONARY CARE UNIT IN SATISFACTORY CONDITION. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SURGICAL PROCEDURE PERFORMED AT THE SITE ON (B)(6) 2011. A REVIEW OF THE SYSTEM LOGS SHOWED THAT NO SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "3499186", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, ISI RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI MITRAL VALVE REPAIR PROCEDURE THAT WAS CONVERTED TO ANOTHER TECHNIQUE. THE LEGAL COMPLAINT ALLEGED THAT DURING THE SURGERY THE ROBOTIC ARMS HAD TOO MUCH PRESSURE APPLIED TO THEM CAUSING THE MACHINE TO JOLT. THE LEGAL COMPLAINT ALSO ALLEGED THAT THE PATIENT EXPERIENCED 15 HOURS OF INTERNAL BLEEDING BEFORE DETERMINING THAT EXPLORATORY SURGERY WAS NEEDED, AND THE SURGERY DISCOVERED THAT THE ROBOTIC ARMS SPLICED AND PUNCTURED THE PATIENT'S LIVER AND SPLEEN. DUE TO THE REPORTED INJURIES SUSTAINED BY THE PATIENT DURING THE DA VINCI ROBOTIC SURGICAL PROCEDURE, THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT HAD TO HAVE MULTIPLE ADDITIONAL MEDICAL TESTS AND PHYSICIAN CONSULTATIONS, AND HAD SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY. THE LEGAL COMPLAINT ALLEGED THAT DESPITE ADDITIONAL TREATMENT, THE PATIENT CONTINUED TO SUFFER FROM ABDOMINAL PAIN, FATIGUE, AND DECREASED ENERGY AND STAMINA." } ], "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": "" } ] }