{ "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": "2955842-2025-05812", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250311", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250213", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "20250311", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20181212", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2310853", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250311", "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": "380601-33", "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": "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": [ "Mechanical Problem", "Mechanical Problem" ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/13/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250311", "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": "20250213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21577312", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250213", "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": "365503140", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED THE REPORTED ISSUE. TO CORRECT THE ISSUE, THE SP CANNULA ID (SCID), AND THE SP ONE AXIS MANIPULATOR (SOAM-C) CIRCUIT BOARDS WERE REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS." }, { "mdr_text_key": "365503141", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE PORT (SP) ADRENALECTOMY, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING AN INVALID CANNULA SYSTEM MESSAGE. PRIOR TO CONTACTING THE TSE, THE CUSTOMER ATTEMPTED TO RESEAT THE CANNULA AND CHANGE OUT THE CANNULA. THE TSE REQUESTED THAT A HARD RESTART BE PERFORMED, BUT THE REPORTED COMPLAINT REMAINED. THE ROBOTIC SINGLE PORT WAS ABORTED. THERE WAS A DELAY OF 40 MINUTES ATTRIBUTED TO TRYING TO TROUBLESHOOT THE SP SYSTEM, AND EVENTUALLY A DECISION WAS MADE TO TAKE THE SP SYSTEM OUT AND BRING THE MULTI-PORT XI SYSTEM IN. THE PROCEDURE WAS COMPLETED WITH A XI SYSTEM WITHOUT FURTHER INCIDENT." }, { "mdr_text_key": "367455897", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SP ONE AXIS MANIPULATOR (SOAM-C) UNIT WAS RECEIVED FOR FAILURE ANALYSIS. THE REPORTED FAILURE WAS CONFIRMED BUT NOT REPLICATED. VISUAL INSPECTION SHOWED NO ISSUE FOUND THAT IS RELATED TO THE REPORT ISSUE. THE SOAM WAS INSTALLED AND TESTED, AND IT FUNCTIONED AS EXPECTED. THE SYSTEM STARTED UP WITHOUT ANY ERROR." }, { "mdr_text_key": "367455898", "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": "04/04/2025" } ] }