{ "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": "2955842-2018-10569", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20181004", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20180830", "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": "776766", "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": [ "Appropriate Device Problem Term/Code Not Available", "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "7936777", "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": "122798430", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "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": "122798431", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, A 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. AFTER THE EVENT OCCURRED, THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN SURGERY. AT THE TIME THE CONVERSION TO OPEN SURGERY WAS PERFORMED, THE ROBOT WAS NOT DOCKED TO THE PATIENT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY VIA OPEN SURGERY. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. AS OF (B)(6) 2018, 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 SINCE THEN. 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: TWO SIMILAR EVENTS OCCURRED AT THE SITE ON (B)(6) 2018 WHILE UNDERGOING PLANNED DA VINCI-ASSISTED MID CAB PROCEDURES. IN BOTH INCIDENTS, TWO DIFFERENT PATIENTS ALSO EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN TO CREATE AN INITIAL INCISION PORT. FOR ADDITIONAL INFORMATION REGARDING THE TWO SIMILAR EVENTS, REFER TO THE MDRS WITH PATIENT IDENTIFIER NUMBERS (B)(6)." } ], "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": "" } ] }