{ "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": "2955842-2023-16850", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20230706", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230612", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20230706", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210126", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2030652", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230706", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-40", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230621", "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": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/05/2023;07/13/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20230706", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230612", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17273220", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230612", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "336649450", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336649451", "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 PATIENT CONCERNED ABOUT NOT HAVING THE SINGLE PORT SURGERY WITH NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ABNORMALITY AFTER THE LAPAROSCOPIC SURGERY, BUT THE PATIENT¿S CURRENT STATUS IS UNKNOWN." }, { "mdr_text_key": "336888696", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336888697", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INITIALLY, FAILURE ANALYSIS (FA) WAS UNABLE TO COMPLETE FA TESTING DUE TO THE 25807 AND 32097 ERRORS. AFTER REPAIRED, THE PATIENT SIDE MANIPULATOR (PSM) PASSED SEVERAL TESTS INCLUDING SERVO TEST, PRELOAD MOTOR HEALTH CHECK, BRAKE SPEC TEST, BRAKE REPEATABILITY TEST, CLUTCH BUTTON CHECK, STERILE ADAPTER (SA) PLUNGER CHECK, SA ENGAGEMENT CHECK, PRELOAD SENSOR CHECK, INSTRUMENT SENSOR CHECK, INSTRUMENT ENGAGE SPLINE, BELT SLIP CHECK, SMOOTHNESS TEST, FRICTION TEST, FRICTION HIGH-SPEED SWEEP, AND BACKLASH TEST." }, { "mdr_text_key": "318972920", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR 25807, 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. DURING FIELD EVALUATION, THE FSE CONDUCTED AN INSPECTION AND CONFIRMED ERROR 25807 OCCURRED CONTINUOUSLY AND WAS NOT RECOVERED BY FAULT OVERRIDE. THE FSE REPLACED THE PSM TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PSM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED ERROR 25807 IN THE SYSTEM LOGS POINTING TO DEGREES OF FREEDOM (DOF) 6 AND REPLICATED IT. THE PSM WAS TESTED ON AN IN-HOUSE SYSTEM WHERE THE UNIT TRIGGERED THE 25807 ON STARTUP. THE COMPLAINT REGARDING ERROR 25807 WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE." }, { "mdr_text_key": "318972921", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD REPEATED RECOVERABLE FAULT 25807 OCCURRED ON THE PATIENT SIDE MANIPULATOR (PSM) 1. THE SAME FAULT OCCURRED EVEN AFTER THE CUSTOMER PRESSED 'RECOVER'. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER PERFORM HARD POWER CYCLE OF THE PATIENT SIDE CART (PSC), BUT THE FAULT PERSISTED. THE CUSTOMER CONVERTED TO LAPAROSCOPY WITH NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, AND THE SYSTEM INITIALIZED WITHOUT ERROR. IT WAS UNKNOWN IF THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. THERE WAS NO INJURY TO THE PATIENT. INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS WERE NOT OBSERVED. THE PROCEDURE WAS DELAYED FOR ABOUT 10 MINUTES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/20/2023;08/07/2023" } ] }