{ "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": "2955842-2025-00189", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250113", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20241219", "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": "20250113", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1234633", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250113", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "400180-03", "catalog_number": "400180", "lot_number": "N/A", "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": [ "Arcing", "Arcing" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/24/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20250113", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20241219", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21145644", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241219", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "361233750", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, THE WRIST OF THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT PROTRUDED THROUGH A CRACK IN THE MCS TIP COVER ACCESSORY, RESULTING IN A BURN INJURY AND SMALL HOLE TO ABDOMINAL WALL MUSCLE TISSUE. SUTURES WERE APPLIED TO RESOLVE THE DEFECT. THERE WAS NO BLEEDING ASSOCIATED WITH THIS EVENT. THE GRAY PORTION OF THE MCS TIP COVER ACCESSORY WAS NOTED TO BE TORN. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE IDENTIFIED AT THE TIME. MONOPOLAR ENERGY SETTINGS WERE 40CUT, 40 COAGULATION. THE DAMAGED MCS TIP COVER ACCESSORY WAS REMOVED FROM THE MCS INSTRUMENT AND REPLACED WITH A NEW ONE. THE PROCEDURE THEN CONTINUED AND WAS COMPLETED AS PLANNED. THE PATIENT IS RECOVERING WELL." }, { "mdr_text_key": "361233751", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND COMPLICATION CANNOT BE DETERMINED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "364470443", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A RETURN MATERIAL AUTHORIZATION (RMA) HAD BEEN ISSUED REQUESTING TO HAVE THE ISI DEVICE RETURNED; HOWEVER, ISI DID NOT RECEIVE THE RMA TO CONFIRM/IDENTIFY THE FAILURE MODE. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ISI REVIEWED THE SITE¿S COMPLAINT HISTORY, WHICH SHOWED NO RELATED COMPLAINTS. A REVIEW OF THE SITE¿S INSTRUMENT SYSTEM LOGS REVEALED NO RELATED ERRORS. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. SINCE THE PRODUCT WAS NOT RETURNED AND THE LOG REVIEW WAS UNABLE TO BE PERFORMED, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED." }, { "mdr_text_key": "364470444", "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": "02/18/2025" } ] }