{ "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": "2955842-2025-46377", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20251126", "manufacturer_address_2": "", "pma_pmn_number": "K250674", "date_of_event": "20251031", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20251126", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250603", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "719175", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251126", "brand_name": "DA VINCI ENERGY", "generic_name": "VESSEL SEALER CURVED", "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": "480522-02", "catalog_number": "480522", "lot_number": "U10250603 0169", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": [ "Failure to Deliver Energy", "Failure to Seal", "Failure to Deliver Energy", "Failure to Seal" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/23/2025;06/01/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "Y", "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": "20251126", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260615", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23662876", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251031", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "390706149", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390706150", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS, HOWEVER THIS VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS NOT USED DURING THE REPORTED EVENT. VISUAL INSPECTION FOUND THE GRIP CABLE LOOSE FROM ITS ORIGINAL POSITION AT THE PROXIMAL END. AS A RESULT OF THE LOOSE GRIP CABLE, THE INSTRUMENT FAILED INITIALIZATION TEST. ADDITIONAL OBSERVATION RELATED TO CUSTOMER REPORTED COMPLAINT WAS THAT THE INSTRUMENT WAS FOUND TO FAIL DURING INITIALIZATION. THE INSTRUMENT WAS PLACE ON AN IN-HOUSE SYSTEM AND FAILED INITIALIZATION ON 3 OF 3 ATTEMPTS. THE SYSTEM DISPLAYED ERROR \"SELF TEST FAILED. REMOVE INSTRUMENT. WARNING: BLADE MAY BE EXPOSED\". LOGS WERE UNAVAILABLE TO CONFIRM THE REPORTED ISSUE. THE LOOSE GRIP CABLE AT THE PROXIMAL LIKELY CAUSED THE GRIPS TO NOT CLOSE, LEADING TO THE INSTRUMENT FAILING SELF-TEST/HOMING (INITIALIZATION) AND AN EXPOSED BLADE IN MOST CASES. THE INSTRUMENT WAS ALSO FOUND TO HAVE LOW TORQUE. INITIALIZATION TEST WAS BYPASSED AND HARD GRIP FORCE TEST PERFORMED. THE INSTRUMENT PASSED THE CUT TEST BUT FAILED TO SEAL. ERROR DISPLAYED \"SEALING MALFUNCTION. PRESS 'ARM SWAP' TO RESTORE CONTROL THEN REMOVE AND REINSTALL. IF ISSUE PERSISTS, DISCARD INSTRUMENT\". ERROR \"INCOMPLETE SEAL CYCLE\" ALSO APPEARED. LOGS WERE UNAVAILABLE TO CONFIRM THE REPORTED ISSUE. THE INSTRUMENT PASSED THE GRIP FORCE TEST." }, { "mdr_text_key": "386257032", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A REVIEW OF THE LOGS FOR THE VESSEL SEALER CURVED INSTRUMENT ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. THE LOGS SHOW 137 SEAL AND 1 BIPOLAR ENERGY MODE EVENTS ASSOCIATED WITH THIS INSTRUMENT." }, { "mdr_text_key": "386257033", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL PANCREATODUODENECTOMY PROCEDURE, THE VESSEL SEALER CURVED INSTRUMENT FAILED TO SEAL, AND THE JAWS BECAME STUCK CLOSED ON TISSUE. THE GRIP RELEASE SLIDER WAS UTILIZED TO OPEN THE JAWS AND RELEASE THE TISSUE. DUE TO FRUSTRATION, THE SURGEON ELECTED TO CONVERT THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY. IT IS UNKNOWN IF ANY ADDITIONAL PORTS WERE PLACED WHEN THE CASE WAS CONVERTED TO A STANDARD LAPAROSCOPIC PROCEDURE. THE VESSEL SEALER CURVED INSTRUMENT HAD AN ISSUE WITH SEALING FROM FIRST USE AND DID NOT RESOLVE AFTER REPEATED USAGE. THERE WERE NO ERROR CODES THAT OCCURRED, AND AUDIBLE TONES OF SEALING, PROGRESS, AND COMPLETION WERE HEARD. THE FOLLOWING INFORMATION IS UNKNOWN: IF THE EVENT INVOLVED INSUFFICIENT SEALING, IF THE SURGEON CUT TISSUE THAT WAS NOT ADEQUATELY SEALED, AND IF THERE WAS BLEEDING ASSOCIATED WITH THE EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/16/2026;06/15/2026" } ] }