{ "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": "2955842-2025-29548", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250717", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250619", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250717", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240801", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2056704", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250717", "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": "380601-51", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250711", "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": "07/10/2025;08/29/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251104", "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": "20250717", "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": "20250619", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22529581", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250619", "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": "375520603", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "375520604", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS DUE TO SYSTEM ERRORS AND WAS REPEATED. IT IS UNKNOW IF CONVERSION RESULTED IN INCREASING PORT SIZE INCISION. IT IS UNKNOW HOW THE PATIENT TOLERATED CONVERSION. THERE WAS NO INJURY TO THE PATIENT. THE SYSTEM WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE CUSTOMER CALLED ISI TSE FOR TROUBLESHOOTING, BUT FULL TROUBLESHOOTING WAS NOT COMPLETED." }, { "mdr_text_key": "375144863", "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 COMPLAINT. ERROR LOG REVIEW BY THE TECHNICAL SUPPORT ENGINEER (TSE) HAD POINTED TO A SENSOR ISSUE THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE RIGHT CART DRIVE. THE SYSTEM WAS THEN TESTED AND VERIFIED AS READY FOR USE. THE RIGHT CART DRIVE INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE." }, { "mdr_text_key": "375144864", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SINGLE PORT DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE PATIENT SIDE SYSTEM (PSS) HAD A RECOVERABLE FAULT. THE SYSTEM HAD INITIALLY POWERED ON WITHOUT ERRORS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO PRESS \"RECOVER FAULT\". THE SITE PRESSED IT, A SECOND RECOVERABLE FAULT OCCURRED, AND THEN THE TSE ADVISED THEM TO DO A HARD POWER CYCLE OF THE PSS; HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED FROM SINGLE PORT TO A TRADITIONAL LAPAROSCOPIC SURGERY." }, { "mdr_text_key": "384251902", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE RIGHT DRIVE CART INVOLVED WITH THIS EVENT HAS BEEN RECEIVED AND ERROR 32101 WAS CONFIRMED AND REPLICATED. UPON VISUAL INSPECTION NO ISSUES WERE FOUND RELATED TO THE REPORTED PROBLEM. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE IT WOULDN'T START ANY TESTS." }, { "mdr_text_key": "384251903", "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": "07/18/2025;09/12/2025" } ] }