{ "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": "2955842-2025-43842", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251105", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251013", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20251105", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240828", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2701706", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251105", "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": "380941-51", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20251021", "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": [ "Grounding Malfunction", "Grounding Malfunction" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/01/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260120", "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": "20251105", "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": "20251216", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23479141", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251013", "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": "390660412", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390660413", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENERGY SHIELD MONITOR (ESM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. UPON VISUAL INSPECTION THE LEFT NEUTRAL CONNECTOR PIN WAS FOUND DAMAGED." }, { "mdr_text_key": "384377484", "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 FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) AS ADVISED; HOWEVER, THE ISSUE WAS STILL ENCOUNTERED WHERE THE GROUND PAD WAS NOT BEING RECOGNIZED. THE MONOPOLAR SETTINGS ON THE BOTTOM DISPLAY OF THE IESU WERE ADJUSTABLE BUT APPEARED VERY FAINT. THE FSE WAS UNABLE TO FIRE MONOPOLAR ENERGY. THE FSE USED A NEW GROUND PAD BUT COULD NOT GET IT TO BE RECOGNIZED, DESPITE PLACING THE GROUND PAD ON THE SKIN, LAYING A PIECE OF METAL ACROSS THE PAD, AND ADJUSTING SALINE LEVELS ON THE FSE SPONGE. THE FSE SOUGHT ADVICE FROM A TECHNICAL SUPPORT ENGINEER (TSE), WHO SUGGESTED THAT THE ENERGY SHIELD MONITOR (ESM) MIGHT NEED TO BE REPLACED. THE TSE THEN ADVISED THE FSE TO REMOVE THE NEUTRAL CONNECTION FROM THE ESM TO THE ERBE AND CONNECT THE GROUND PAD DIRECTLY TO THE ERBE. THE ERBE WAS THEN ABLE TO RECOGNIZE THE GROUND PAD. THE FSE REPLACED THE ESM TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE." }, { "mdr_text_key": "384377485", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SINGLE PORT (SP) DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A \"NEUTRAL PAD IS NOT CONNECTED\" MESSAGE. THE CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT PRIOR TO CALLING, THE SITE HAD TRIED TO POWER CYCLE THE INTEGRATED ELECTROSURGICAL UNIT (IESU) AND TRIED A NEW NEUTRAL PAD WITH NO RESOLVE. THE STAFF TRIED A NEW INSTRUMENT AND MONOPOLAR CABLE. THE CSR HAD THE CUSTOMER HARD POWER CYCLE THE IESU AND SYSTEM. THE NEUTRAL PAD ICON WAS STILL SHOWING RED. THE CUSTOMER ADVISED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY WERE CONVERTING FROM SINGLE PORT TO A LAPAROSCOPIC PROCEDURE." } ], "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": "12/16/2025" } ] }