{ "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": "2955842-2016-00862", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20161202", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20161021", "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": "20161202", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "793450", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161202", "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, A70P5D", "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" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20161202", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Coma", "Coma" ] } ], "distributor_city": "", "date_report": "20161105", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6143161", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20161105", "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": "61400410", "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 POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. AFTER UNDERGOING A DA VINCI ASSISTED SINGLE-VESSEL SMALL THORACOTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE BLEEDING FROM THE INTERNAL MAMMARY ARTERY WHICH LED TO DIMINISHED BRAIN FUNCTION. THE ROOT CAUSE OF THE BLEEDING IS UNKNOWN. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." }, { "mdr_text_key": "61400411", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 2 WEEKS POST A SUCCESSFUL DA VINCI ASSISTED SINGLE-VESSEL SMALL THORACOTOMY PROCEDURE; THE PATIENT HAD DIMINISHED BRAIN FUNCTION. CURRENTLY THE PATIENT IS IN A COMA. ON 11/16/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO ASSISTED DURING THE PROCEDURE; HE STATED THAT APPROXIMATELY TWO WEEKS POST-OPERATIVELY, THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM WITH DIMINISHED BRAIN FUNCTION. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AFTER THE INTERNAL MAMMARY ARTERY THAT HAD BEEN HARVESTED ROBOTICALLY DURING THE PROCEDURE TWO WEEKS PREVIOUSLY WAS FOUND TO BE BLEEDING. THE SURGEON STATED HE COULD NOT CONFIRM ANY ROOT CAUSE FOR THE BLEEDING; HOWEVER, HE STATED THAT SINCE IT HAPPENED TWO WEEKS AFTER THE PROCEDURE HE BELIEVES THE COAGULUM COULD HAVE SLOUGHED OFF. AS PER THE HOSPITAL'S FOLLOW THE HEART PROGRAM, THE PATIENT WAS MONITORED AND WAS DOING WELL UNTIL THIS ACUTE EVENT HAPPENED. THE IMA HARVESTING WAS DONE ROBOTICALLY AND THE REST OF THE PROCEDURE WAS DONE AS A TRADITIONAL OPEN PROCEDURE. ON FURTHER FOLLOW UP WITH THE ISI CLINICAL SALES MANAGER IT WAS STATED THAT WHEN THE PATIENT CAME IN WITH A DIMINISHED BRAIN FUNCTION THE BLEEDING WAS CONTROLLED BY ANOTHER UNSPECIFIED SURGICAL PROCEDURE. THE SURGEON STATED THAT THE POTENTIAL COAGULUM FAILURE COULD HAVE BEEN RELATED TO THE FACT THAT THE ERBE GENERATOR, THAT IS INTEGRATED AND SOLD WITH THE DE VINCI XI SURGICAL SYSTEM, DOES NOT GIVE THE OPTION OF INCREASING THE SETTING IN SMALLER INCREMENTS (WHICH WOULD HELP WITH PURE COAGULATION). THE SURGEON STATED THAT HE HAD SET THE ERBE GENERATOR AT 2 FOR THIS PROCEDURE; BUT WOULD HAVE PREFERRED TO SET IT AT 1.5, IF THE ERBE GENERATOR HAD A SETTING BETWEEN 1 AND 2. THE SURGEON DOES NOT BELIEVE THE CAUSE OF THE PATIENT'S BLEEDING HAD ANYTHING TO DO WITH EITHER THE DA VINCI SYSTEM OR INSTRUMENTS (INCLUDING THE INTEGRATED ERBE GENERATOR) SINCE THE SURGEON SETS THE SETTINGS ON A GENERATOR BASED ON PREFERENCE; THERE WAS NO MALFUNCTION OF THE SYSTEM IN THIS CASE. HOWEVER, MOVING FORWARD HE STATED HE WILL USE THE VALLEY LAB GENERATOR SINCE THERE IS A WIDER RANGE OF SETTINGS." } ], "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": "" } ] }