{ "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": "2955842-2025-46170", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251124", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251028", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20251124", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240418", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "739453", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251124", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM CART", "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": "380941-50", "catalog_number": "380941", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114742", "udi_public": "(01)00886874114742", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Output Problem", "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/03/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260309", "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": "20251124", "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": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260223", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23632269", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251028", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "385909536", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE FAULT INVOLVING THE ERBE GENERATOR, PROMPTING THE SURGEON TO CONVERT TO THE PROCEDURE TO A CONVENTIONAL VAGINAL APPROACH. THE CUSTOMER INSPECTED THE GENERATOR BEFORE USE AND NO UNUSUAL FINDINGS WERE SEEN. A SELF-TEST WAS PERFORMED AND NO ERROR MESSAGES WERE OBSERVED. ACCORDING TO THE CUSTOMER, THE GENERATOR HAD BEEN SHOWING AN ERROR INTERMITTENTLY WHICH EVENTUALLY BECAME CONSTANT WHEN FIRING MONOPOLAR OR BIPOLAR INSTRUMENTS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO CHANGE THE BIPOLAR SETTING, BUT THE ERROR PERSISTED. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO ADVERSE COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "385909537", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC (ISI) FIELD SERVICE ENGINEER (FSE) CONDUCTED A SITE VISIT TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND DEEMED READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SYSTEM LOGS WAS PERFORMED, WITH NO RELEVANT ERRORS DETECTED." }, { "mdr_text_key": "394229231", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: D9, H2 H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REPORTED FAILURE WAS CONFIRMED AND REPLICATED. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE GENERATOR WAS ANALYZED AND FOUND TO HAVE AN ERROR UPON STARTUP WHEN PLACED ON AN IN-HOUSE SYSTEM. THIS ERROR DURING THE POWER-ON TEST CONFIRMED THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT." }, { "mdr_text_key": "394229232", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "02/23/2026" } ] }