{ "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": "2955842-2025-40792", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251009", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250917", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "UK", "manufacturer_contact_area_code": "408", "date_added": "20251009", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231212", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1067712", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251009", "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": "N/A", "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": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Output Problem", "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/06/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260310", "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": "20251009", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20251219", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23260335", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250917", "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": "390683446", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PATIENT SIDE MANIPULATOR (PSM) WAS ANALYZED AND FOUND TO BE UNABLE TO RECOGNIZE ANY INSTRUMENT WHEN INSTALLED ON AN IN-HOUSE SYSTEM. THE PSM WAS DISASSEMBLED FOR FURTHER TROUBLESHOOTING AND IDENTIFIED THE MAGNET ON THE RETENTION PLATE LEFT SPRING PIN HAD COME OFF." }, { "mdr_text_key": "390683447", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "382181880", "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 WENT ON SITE AND REPLACED THE PSM DUE TO ERRORS 31009 AND 31010. 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." }, { "mdr_text_key": "382181881", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, PATIENT SIDE MANIPULATOR (PSM) 2 FLASHING ORANGE WHILE THE INSTRUMENT WAS MOUNTED. THE NURSE STATED THAT BEFORE CALLING IN, THE SYSTEM WAS ALREADY RESTARTED AND REDRAPED. THE TECHNICAL SERVICE ENGINEER (TSE) CHECKED THE EVENT LOGS AND FOUND ERROR 31009 AND 31010 POINTS TO NOT WORKING INSTRUMENT PRESENCE PINS. PRESENCE PIN RECALIBRATION MIGHT BE NEEDED. THE PROCEDURE WAS CONVERTED TO MULTI-PORT." } ], "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": "12/19/2025" } ] }