{ "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": "2955842-2025-22661", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250529", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250502", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250529", "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": "663791", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250529", "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", "date_returned_to_manufacturer": "20250506", "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": [ "No Device Output", "No Device Output" ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/29/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251006", "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": "20250529", "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": "20250502", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22108990", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250502", "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": "371300427", "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 CONFIRMED PATIENT SIDE MANIPULATOR (PSM) #1 WOULD NOT ALLOW INSTRUMENT TO ENGAGE. THE FSE THEN CHECKED THE LOGS AND CONFIRMED AN ERROR ON PSM #1. TO CORRECT THE ISSUE, THE PSM WAS REPLACED BY THE FSE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PSM INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PSM WAS ANALYZED AND DURING VISUAL INSPECTION, THE RETENTION PLATE LEFT SPRING PIN WAS FOUND TO BE BROKEN OFF. THE UNIT WAS INSTALLED ONTO A TEST SYSTEM WHERE WHEN INSTALLING AN INSTRUMENT, THE SYSTEM WOULD FAULT AND PROMPT THE USER TO REINSTALL THE INSTRUMENT DUE TO THE BROKEN PIN. REVIEW OF THE SYSTEM ERROR LOGS SHOWED MULTIPLE ERRORS." }, { "mdr_text_key": "371300428", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED SP SURGICAL PROCEDURE THE CUSTOMER WAS UNABLE TO GET AN INSTRUMENT TO ENGAGE ON UNIVERSAL SURGICAL MANIPULATOR (USM) #1. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. PRIOR TO CALLING IN, THE CUSTOMER REBOOTED THE SYSTEM AND REPLACED THE DRAPE WITH NO CHANGE. THE CUSTOMER TRIED MULTIPLE INSTRUMENTS WITH NO CHANGE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) NOTED AN ERROR IN THE LOGS. THE TSE HAD THE CUSTOMER RESEAT THE STERILE ADAPTER SEVERAL TIMES WITH NO CHANGE. THE CUSTOMER CONFIRMED THAT THE DRAPE WAS NOT GETTING CAUGHT. THE TSE HAD THE CUSTOMER PERFORM A HARD REBOOT OF THE SYSTEM WITH NO CHANGE. THE CUSTOMER STATED THAT THE SURGEON WAS UNABLE TO PERFORM THE PROCEDURE WITH JUST 3 ARMS. THE SURGEON DID NOT DISABLE OR DISCONTINUE USE OF THE USM DUE TO THE ISSUE. TO RESOLVE THE ISSUE, CUSTOMER REMOVED THE DA VINCI SP SURGICAL SYSTEM AND WHEELED IN A DA VINCI XI (MULTI-PORT) SURGICAL SYSTEM TO COMPLETE THE CASE. ADDITIONAL PORTS WERE PLACED TO PERFORM THE SURGICAL PROCEDURE. THE PATIENT TOLERATED THE CHANGE. THE PATIENT HAD THE INITIAL SP INCISION PLACED, WHICH WAS CLOSED BEFORE CONVERTING THE CASE TO THE DA VINCI XI SYSTEM." }, { "mdr_text_key": "381764133", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: THE SURGEON DID DISABLE/DISCONTINUE USE OF THE SINGLE PORT (SP) PATIENT CART ARM DUE TO THE ISSUE, AND A DA VINCI XI MULTIPORT SYSTEM WAS USED TO COMPLETE THE PROCEDURE." }, { "mdr_text_key": "381764134", "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": "09/23/2025" } ] }