{ "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": "2955842-2015-01134", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150826", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20150727", "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": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150826", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "565765", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150826", "brand_name": "DA VINCI XI 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": "IS4000 A7.0P4", "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 Movement" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20150826", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Perforation" ] } ], "distributor_city": "", "date_report": "20150727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5033351", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150727", "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": "24192029", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. BASED ON THE FIELD EVALUATION PERFORMED BY THE TFS, THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON CLAIMED THAT ARM 4 MOVED ON ITS OWN DURING THE DA VINCI MITRAL VALVE REPAIR PROCEDURE AND THE PATIENT'S HEART WAS PUNCTURED. HOWEVER, A TFS EVALUATED THE DA VINCI SURGICAL SYSTEM INVOLVED WITH THE PATIENT'S REPORTED INJURY AND WAS UNABLE TO REPLICATE THE ALLEGED ISSUE WITH ARM 4." }, { "mdr_text_key": "24192030", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI MITRAL VALVE REPAIR PROCEDURE, THE SURGEON ALLEGED THAT ARM 4 ON THE PATIENT SIDE CART (PSC) MOVED ON ITS OWN AND AS A RESULT, THE PATIENT'S HEART WAS PUNCTURED. THE SURGEON WAS ABLE TO REPAIR THE INJURY AND COMPLETE THE SURGICAL PROCEDURE. ON (B)(4) 2015, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE WITH ARM 4 ON THE PSC. THE TFS TESTED THE DA VINCI SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. THE TFS FOLLOWED UP WITH THE SITE AND ALSO VERIFIED THAT SUBSEQUENT DA VINCI SURGICAL PROCEDURES HAD BEEN PERFORMED WITH THE DA VINCI SYSTEM AND THERE WERE NO RECURRENCES OF THE ALLEGED ISSUE WITH ARM 4. ON (B)(4) 2015, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. THE CSR INDICATED THAT THE REPORTED EVENT OCCURRED TOWARDS THE BEGINNING OF THE SURGICAL PROCEDURE AFTER THE SURGEON HAD OPENED THE PERICARDIUM WITH A PERMANENT CAUTERY SPATULA INSTRUMENT INSTALLED ON ARM 4. AT THE TIME THE EVENT OCCURRED, THE CSR INDICATED THAT THE PATIENT WAS ON BYPASS AND THEREFORE NO BLEEDING OCCURRED. THE SURGEON WAS ABLE TO CLOSE THE PUNCTURE WOUND THAT WAS DESCRIBED AS BEING THE WIDTH OF A CANNULA WITH SUTURES. THE SURGEON SUCCESSFULLY COMPLETED THE SURGICAL PROCEDURE. THE CSR SPOKE TO A SURGICAL ASSISTANT WHO WAS PRESENT DURING THE SURGICAL PROCEDURE AND WAS INFORMED THAT THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. THERE WAS ALSO NO ALLEGATION FROM THE SURGEON THAT A MALFUNCTION OF THE PERMANENT CAUTERY SPATULA INSTRUMENT HAD OCCURRED." } ], "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": "" } ] }