{ "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": "2955842-2025-46388", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251202", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251104", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "408", "date_added": "20251202", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240329", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "272737", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251202", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE 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": "380601-50", "catalog_number": "380601", "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": "00886874114605", "udi_public": "(01)00886874114605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/09/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260511", "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": "20251202", "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": "20260306", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23697963", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251104", "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": "394867475", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PATIENT SIDE MANIPULATOR (PSM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PSM WAS ANALYZED AND FOUND TO HAVE AN ERROR. A LOG REVIEW SHOWED MULTIPLE ERRORS INCLUDING INSTRUMENT RECOGNITION ERRORS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, A SMALL AMOUNT OF FLUID INTRUSION COULD BE SEEN. THE UNIT WAS THEN INSTALLED ONTO A TEST SYSTEM WHERE ON STARTUP, THE PSM WAS DETECTING AN INSTRUMENT WHEN ONE WAS NOT INSTALLED. THE INSTRUMENT RECOGNITION ERRORS WERE SEEN IN THE SYSTEM LOGS INDICATING THAT A RADIO FREQUENCY IDENTIFIER (RFID) WAS NOT PRESENT/DETECTED. THE PSM WAS PARTIALLY DISASSEMBLED TO INSPECT THE RFID AND HEAVY AMOUNTS OF FLUID INTRUSION WERE SEEN ALONG THE PRINTED CIRCUIT ASSEMBLY (PCA)." }, { "mdr_text_key": "394867476", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "386594227", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE ERROR ISSUE POINTING TO A PATIENT SIDE MANIPULATOR (PSM). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASSISTED THE CUSTOMER WITH A HARD POWER CYCLE, SYSTEM REBOOT, AND DRAPE REMOVAL, BUT THE SYSTEM CONTINUED TO DISPLAY THE ERROR AT EACH POWER-ON. ADDITIONALLY, THE LED ON THE PSM WAS AMBER. DUE TO THE SYSTEM ISSUE, THE CUSTOMER ELECTED TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY AND TWO ADDITIONAL PORTS WERE ADDED. ALSO, THERE WAS A PROCEDURE DELAY OF 15 MINUTES REPORTED. THE PATIENT REPORTEDLY TOLERATED THE CONVERSION TO TRADITIONAL LAPAROSCOPIC SURGERY." }, { "mdr_text_key": "386594228", "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 REPRODUCE THE ERROR AND REPLACED THE PATIENT SIDE MANIPULATOR (PSM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS." } ], "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": "03/06/2026" } ] }