{ "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": "2955842-2013-02431", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130703", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20130604", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130705", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "304434", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130703", "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 A5.1P7", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20130610", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20130703", "sequence_number_treatment": [ "DA VINCI S SURG. SYS. INSTRUMENTS & ACCESSORIES." ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20130604", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3206001", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130604", "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": "18806662", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) ARM 1 WAS NOT ROTATING. WITH THE ASSISTANCE OF AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THE SITE INSTALLED DIFFERENT INSTRUMENTS AND RESEATED THE STERILE ADAPTER, HOWEVER, THE ISSUE PERSISTED. THE SITE INDICATED THAT THE SURGEON ENCOUNTERED THE ISSUE EVERY TIME HE CHANGED PSMS. THE SITE ADVISED THE TSE THAT THEY WERE CONTINUING WITH THE CASE. APPROXIMATELY 1 HOUR LATER, THE SITE CALLED ISI BACK FOR TECHNICAL SUPPORT ASSISTANCE. THE SITE INDICATED TO THE TSE THAT THE SYSTEM WAS NOT WORKING CORRECTLY AND THAT THE PSM WAS SHAKING. THE SITE DECLINED TO TROUBLESHOOT THE ISSUE WITH THE TSE, AS THEY WERE IN THE MIDDLE OF THE PROCEDURE. THE SITE REQUESTED THAT THE TSE DISPATCH AN ISI FIELD SERVICE ENGINEER TO EVALUATE THE SYSTEM." }, { "mdr_text_key": "19291342", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DURING THE FIELD INVESTIGATION PERFORMED BY THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE), THE FSE LEARNED THAT THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN, DUE TO THE PATIENT'S HEART HAVING BEEN PUNCTURED. THE FSE WAS ALSO TOLD BY THE SITE'S NURSE MANAGER THAT A POWER FLUCTUATION OR LOSS OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, THE NURSE MANAGER INDICATED THAT IT IS UNKNOWN IF THE POWER ISSUE CONTRIBUTED TO THE ISSUE EXPERIENCED BY THE SITE. THE FSE WAS UNABLE TO REPLICATE SHAKING ON PATIENT SIDE MANIPULATOR (PSM) 1 DURING FUNCTIONAL TESTING OF THE SYSTEM USING TEST INSTRUMENTS. ISI CONTACTED THE INITIAL REPORTER AND SHE INDICATED THAT THE PSM WAS NOT SHAKING, AS INITIALLY REPORTED, BUT WHILE RETRACTING TISSUE, THE FORCE OF THE WAS NOT AS STRONG AS NORMAL AND THE PATIENT'S TISSUE WAS SLIPPING. ISI ENGINEERING ALSO THE SITE'S SYSTEM LOGS AND CONFIRMED THAT THE SYSTEM LOST AC POWER DURING THE SURGICAL PROCEDURE AND THE AC POWER WAS RESTORED AFTER 2 MINUTES. NO OTHER SYSTEM ERROR CODES WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ISSUE EXPERIENCED BY THE SITE. DURING EVALUATION OF THE SITE'S SYSTEM, THE FSE FOUND THAT THE FRICTION WAS HIGH FOR AXIS 4 ON PSM 1 AND THE FRICTION WAS HIGH FOR AXIS 1 ON PSM 2. PSM 1 AND PSM 2 WERE REPLACED TO REPAIR THE SYSTEM. PSM 1 AND PSM 2 WERE RETURNED FOR EVALUATION. ENGINEERING EVALUATION FOUND THAT PSM 1 FAILED FRICTION TESTING FOR AXIS 1 AND AXIS 2. THE HARMONIC DRIVES FOR AXIS 1 AND 2 WERE REPLACED TO REPAIR PSM 1. ENGINEERING EVALUATION OF PSM 2 FOUND THAT AXIS 4 FAILED FRICTION TESTING. THE UPPER PULLEYS FOR LINK 5 AND 6 WERE SLIDING OFF THE BEARING, ADDING UNWANTED FRICTION. THE PULLEY ASSEMBLIES WERE REPLACED TO REPAIR PSM 2. ENGINEERING WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE, AS PSM 2 PASSED SOFTWARE TESTING, AND NORMAL MODE TESTING USING ISI IN-HOUSE TEST STERILE ADAPTERS AND INSTRUMENTS. THE PSM'S CANNULA MOUNT WAS FOUND TO BE CURRENT AND WITHIN SPECIFICATION. AS A PRECAUTION, AN EMBEDDED SERIALIZER FOR THE INSTRUMENT INTERFACE (ESII) BOARD WAS REPLACED. ON (B)(6) 2013, ISI CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT HE WAS PERFORMING A LEFT DYNAMIC ATRIAL RETRACTION USING AN ATRIAL RETRACTOR INSTRUMENT WHEN THE PUNCTURE TO THE PATIENT'S HEART OCCURRED. THE SURGEON INDICATED THAT IT WAS HIS BELIEF THAT THE DAMAGE TO THE PATIENT'S HEART WAS DUE TO A MALFUNCTION OF THE PSM. THE SURGEON ALSO BELIEVES THAT THE MALFUNCTION OF THE PSM OCCURRED AS A RESULT OF WEAR AND TEAR TO THE SYSTEM OVER TIME. THE SURGEON INDICATED THAT THE SURGICAL STAFF SHOULD HAVE INSPECTED THE SYSTEM PRIOR TO HIS USE OF THE SYSTEM TO ENSURE THAT IT WAS FUNCTIONING PROPERLY. THE SURGEON INDICATED THAT THE PATIENT TOLERATED THE OPEN PROCEDURE WELL AND WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT IS RECOVERING WELL AND HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI S MITRAL VALVE REPAIR PROCEDURE." } ], "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": "" } ] }