{ "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": "2955842-2023-17072", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230714", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20230616", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "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": "SW", "manufacturer_contact_area_code": "408", "date_added": "20230714", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211013", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "693202", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230714", "brand_name": "DA VINCI", "generic_name": "UNKNOWN", "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": "380451-06", "catalog_number": "380451", "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": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/17/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20230714", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "69 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230616", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17329981", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230616", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "336086118", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 17-JUL-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT: THE MASTER TOOL MANIPULATOR 2 (MTM2) WAS RECEIVED, AND INVESTIGATIONS COMPLETED. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPRODUCED THE CUSTOMER REPORTED COMPLAINT. DURING EVALUATION, ERROR 23025 WAS OBSERVED ALONG AXIS 1, CAUSING THE MTM2 TO FAIL DURING POWER UP. A GOLDEN MOTOR WAS INSTALLED ON AXIS 1. ALL TESTS PERFORMED VIA DTE AND MATLAB PASSED. ORIGINAL PARTS WERE RE-INSTALLED AND MTM2 FAILED AGAIN FOR ERROR 23025 DURING POWER UP. THE FOLLOWING PARTS WILL BE REPLACED AS A FIX: AXIS 1 MOTOR, A1 MOTOR CABLE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE." }, { "mdr_text_key": "319296017", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED EXTENDED TOTALLY EXTRAPERITONEAL (ETEP) INCISIONAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED A CONVERSION TO OPEN AND A SUBSEQUENT SURGICAL PROCEDURE. THE ISSUE OCCURRED INITIALLY WHEN THE SYSTEM ENCOUNTERED A RECOVERABLE FAULT RELATED TO ARM 3. THE FAULT WITH ERROR CODE 23025 REPEATED ITSELF AS SOON AS RECOVERY WAS ATTEMPTED. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LIVE LOGS AND VERIFIED SEVERAL INSTANCES OF ERROR CODE 23025, INDICATING AXIS 1 ON RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SURGEON SWITCHED HAND CONTROL ASSIGNMENTS WITH ARM 3 BEING CONTROLLED BY THE LEFT MASTER TOOL MANIPULATOR (MTML) AND MTMR CONTROLLING ARM 1 TO RULE OUT ANY ARM ISSUES. THE FAULT RETURNED AND WAS STILL POINTING AT THE MTMR. THE SYSTEM WAS THEN POWER CYCLED, WHICH DID NOT RESOLVE THE ISSUE. THE MTMR WAS PUT THROUGH AN EXERCISING MOVEMENT AND A HARD POWER CYCLE WAS PERFORMED WITH THE EMERGENCY POWER OFF (EPO) OF THE SYSTEM, BUT THIS ALSO DID NOT RESOLVE THE ISSUE. THE SURGEON MADE THE CLINICAL DECISION TO OPEN DUE TO THE MTMR BEING INOPERABLE. THE PATIENT TOLERATED THE OPEN PROCEDURE. HOWEVER, POST-OPERATIVELY, THE PATIENT HAD A WOUND RUPTURE AND WAS TAKEN BACK TO THE OPERATING ROOM FOR A SUBSEQUENT SURGICAL PROCEDURE. THE MESH RECENTLY IMPLANTED FOR THE HERNIA WAS REMOVED, A NEW MESH WAS INSERTED, AND THE ANTERIOR FASCIA WAS RE-SUTURED." }, { "mdr_text_key": "319296018", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE RIGHT MASTER TOOL MANIPULATOR (MTMR) DUE TO ERROR 23025 ON MTMR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE MASTER TOOL MANIPULATOR ¿ RIGHT (MTMR) INVOLVED WITH THIS EVENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOG WAS COMPLETED, AND THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS WERE OBSERVED: ERROR CODE 23025, ERROR CLASS 6: ENCODER QUADRATURE FAULT ON MTMR AXIS 1. A REVIEW OF THE ADVANCED SYSTEM LOG WAS COMPLETED AND CONFIRMED THE 23025 ERROR ON MTMR. APPROXIMATELY FIVE MINUTES INTO THE PROCEDURE, THE 23025 ERROR WAS TRIGGERED ON THE MTMR. THE USER ATTEMPTED TO RECOVER FROM THE FAULT TEN TIMES WITHOUT A POSITIVE RESULT. THE 23025 ERROR INDICATES AN ENCODER FAULT ON THE MTMR AXIS 1. LOOKING AT THE SYSTEM LOGS FROM BEFORE THE PROCEDURE, THIS FAULT FIRST MANIFESTED AS A 23015 ERROR. THE 23015 IS ALSO AN ENCODER FAULT ON THE MTMR AXIS 1. THE FIRST DATE OF OCCURRENCE WAS (B)(6)2023." } ], "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": "08/09/2023" } ] }