{ "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": "2955842-2025-14314", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250415", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250320", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SW", "manufacturer_contact_area_code": "408", "date_added": "20250415", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231229", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2031759", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250415", "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": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Misassembly by Users", "Misassembly by Users" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "health_professional": "", "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": "20250415", "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": "20250320", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21841086", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250320", "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": "368189413", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NEUTRAL GROUNDING PAD WAS NOT RECOGNIZED BY THE ENERGY SHIELD MONITOR (ESM). BEFORE CONTACTING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER ATTEMPTED TO RESOLVE THE ISSUE BY REPLACING THE NEUTRAL PAD, BUT THE PROBLEM PERSISTED. THE CUSTOMER ALSO CONNECTED THE NEUTRAL PAD DIRECTLY TO THE ERBE GENERATOR, WHERE THE ICON APPEARED GREEN. THE TSE THEN INSTRUCTED THE CUSTOMER TO RESEAT BOTH THE INSTRUMENT AND THE NEUTRAL CABLE ON THE ESM; HOWEVER, THE ISSUE CONTINUED. THE TSE FURTHER ADVISED ATTACHING THE NEUTRAL PAD TO THE CUSTOMER¿S ARM TO CHECK ITS STATUS, BUT THE FAULT REMAINED. FINALLY, THE TSE GUIDED THE CUSTOMER THROUGH A COMPLETE POWER CYCLE OF THE ESM, YET THE ERROR PERSISTED. AS A RESULT, THE PROCEDURE WAS ABORTED AFTER ANESTHESIA WAS ADMINISTERED AND PORTS HAD BEEN PLACED." }, { "mdr_text_key": "368189811", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE REPORTED EVENT. UPON ARRIVAL, THE FSE DISCOVERED THAT THE NEUTRAL ELECTRODE CABLE FROM THE ENERGY SHIELD MONITOR WAS INCORRECTLY ROUTED. AFTER CORRECTLY RESEATING THE CABLE, THE ISSUE WAS RESOLVED. NO PRODUCT WILL BE RETURNED FOR FAILURE ANALYSIS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER SHOWS THE NEUTRAL ADAPTER PLUGGED INTO THE NEUTRAL RECEPTACLE ON THE ENERGY SHIELD MONITOR (ESM). WITH THE SETUP SHOWN IN THE IMAGE, THE ESM WILL NOT FUNCTION AS INTENDED. ACCORDING TO THE SP INSTRUMENTS AND ACCESSORIES USER MANUAL, THE NEUTRAL ADAPTER SHOULD BE PLUGGED INTO THE NEUTRAL RECEPTACLE ON THE ERBE GENERATOR. ADDITIONALLY, THE PATIENT NEUTRAL PAD SHOULD BE CONNECTED TO THE NEUTRAL RECEPTACLE ON THE ENERGY SHIELD MONITOR." } ], "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": "" } ] }