{ "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": "I", "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": "2955842-2018-10570", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20181004", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20180904", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20181004", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "775516", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181004", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "generic_name": "VISION SIDE SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "381121-29", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20181004", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20180905", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7936881", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20180905", "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": "122800944", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2018. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AT THE START OF A PLANNED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION OCCURRED WHILE THE SURGEON WAS APPLYING ENERGY WITH A BOVIE PEN TO CREATE AN INITIAL INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE REGULAR HEART RHYTHM. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE CANNOT BE DETERMINED." }, { "mdr_text_key": "122800945", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING THE START OF A DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AT THE TIME THE EVENT OCCURRED, THE ROBOT WAS NOT DOCKED TO THE PATIENT YET. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY AND NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. SINCE THE DATE OF THE EVENT, THE SITE HAS PERFORMED MULTIPLE SUBSEQUENT DA VINCI-ASSISTED SURGICAL PROCEDURES WITH THE SAME DA VINCI SURGICAL SYSTEM AND THERE HAVE BEEN NO REOCCURRENCES OF THE REPORTED ISSUE. THE SITE HAS INSPECTED THE BOVIE PEN AND NO ISSUES WERE IDENTIFIED. THE PLUGS IN THE OR AND GROUNDING PADS HAVE NOT CHANGED. THE SITE HAS NOT DETERMINED THE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE. NOTE: THIS WAS THE FIRST OF TWO DA VINCI-ASSISTED MID CAB PROCEDURE PERFORMED BY THE SURGEON ON THE SAME DAY (EVENT DATE = (B)(6) 2018) AND WITH A SIMILAR REPORTED OPERATIVE COMPLICATION (I.E. DANGEROUS HEART RHYTHMS). REFER TO THE MDR WITH PATIENT IDENTIFIER #(B)(6) FOR INFORMATION REGARDING THE SECOND REPORTED SIMILAR EVENT." } ], "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": "" } ] }