{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2025-49033", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20251219", "manufacturer_address_2": "", "pma_pmn_number": "K232610", "date_of_event": "20251120", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20251219", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "40007", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251219", "brand_name": "DA VINCI 5", "generic_name": "INSUFFLATOR AND TUBE SET WITH SMOKE EVACUATION", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "373750-20", "catalog_number": "373750", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20251203", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": "12/19/2025;02/18/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260508", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20251219", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abnormal Blood Gases", "Abnormal Blood Gases" ] } ], "distributor_city": "", "date_report": "20260311", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23847199", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251120", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "388071796", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE DA VINCI INSUFFLATOR WAS REPLACED DUE TO THE REPORTED EVENT ALTHOUGH NO ISSUES WERE DOCUMENTED WITH THE INSUFFLATOR DURING THE FSE'S VISIT AND TESTING. THE DA VINCI SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE DA VINCI INSUFFLATOR WAS RECEIVED FOR FAILURE ANALYSIS INVESTIGATIONS. THE REPORTED EVENT WAS NOT REPLICATED OR CONFIRMED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. AN INSUFFLATOR FUNCTIONAL TEST WAS PERFORMED AND THE UNIT PASSED ALL TESTS. NOTHING SEEMED TO BE WRONG WITH THE INSUFFLATOR AND NO AIR LEAKAGE WAS FOUND." }, { "mdr_text_key": "388071797", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE PATIENT WAS TRAPPING CO2 AND HAD TO BE REPOSITIONED TO RESOLVE THE ISSUE. THE ANESTHESIOLOGIST HAD DIFFICULTY OXYGENATING THE PATIENT DUE TO THIS EVENT AND WERE NOT ABLE TO PROPERLY VENTILATE THE PATIENT. THE CUSTOMER REPORTED THAT THEY BELIEVE THIS EVENT WAS CAUSED BY THE DA VINCI INSUFFLATOR EVACUATION PORT. THE CUSTOMER INDICATED THAT THE PATIENT WAS TRAPPING CO2 AND THAT THE INSUFFLATOR PRESSURE MAY HAVE BEEN PREVENTING THE STAFF FROM OXYGENATING THE PATIENT. THE PATIENT WAS REPORTEDLY FINE POST-OPERATIVELY AND WAS ONLY OBSERVED LONGER THAN PLANNED DUE TO THIS EVENT." }, { "mdr_text_key": "390342309", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H11. THE INSUFFLATOR LOGS FOR THIS PROCEDURE WERE REVIEWED. THE TARGET PRESSURE WAS SET AT 15 MMHG FROM 1:15 PM (GMT) TO 3:35 PM. THE TARGET PRESSURE WAS SET TO 12 MMHG FROM 3:35 PM TO 4:45 PM. THE ACTUAL PRESSURE MEASURED SIMILAR TO THE TARGET PRESSURE, EXCEPT FROM 2:18 PM TO 2:26 PM WHERE ACTUAL PRESSURE MEASURED BETWEEN 0.07 MMHG AND 4.59 MMHG. AT 4:01 PM THE ACTUAL PRESSURE WAS MEASURED AT 0 MMHG FOR THE REMAINDER OF THE PROCEDURE." }, { "mdr_text_key": "390342310", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "395231140", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "395231141", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: B2, H2, H6, H11. THE SURGEON NOTED THAT THEY SET THE FLOW TO 40 WHEN USING THE DA VINCI INSUFFLATOR. THE SURGEON CLARIFIED THAT THIS EVENT WAS THE PATIENT EXPERIENCING SUBCUTANEOUS EMPHYSEMA. SHE SAID TWO OF THE PATIENTS THAT EXPERIENCED THIS EVENT HAD TO BE HOSPITALIZED AND OBSERVED UNTIL THE SUBCUTANEOUS EMPHYSEMA WAS RESOLVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/14/2026;03/11/2026" } ] }