{ "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": "2955842-2024-20052", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241003", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20240905", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20241003", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200422", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2016608", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241003", "brand_name": "DA VINCI XI", "generic_name": "ASSY,PSCART,IS4000,4-ARM,P9B", "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": "380652-48", "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": "00886874110720", "udi_public": "(01)00886874110720", "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": "10/23/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20241003", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240905", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20359589", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240905", "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": "353250851", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT THEY TRIED TO CONNECT A SCISSOR ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 AND THE ERROR 32098 APPEARED. THE CUSTOMER TRIED DISCONNECTING THE INSTRUMENT AND CONNECTING IT BACK AGAIN BUT THERE WAS NO IMPROVEMENT. THEY REBOOTED AND HARD POWER CYCLED THE SYSTEM SEVERAL TIMES WITH NO SUCCESS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TRIED CHECKING ERROR LOGS, BUT THE SYSTEM WAS NOT CONNECTED TO ONSITE. THE TSE ASKED THEM IF THEY COULD DISABLE THE USM AND USE THE OTHER THREE ARMS, WHICH WAS THE CASE. THE TSE EXPLAINED THAT USM 4 WOULD NOT BE USABLE AND ASKED THEM IF THEY COULD CONTINUE SURGERY WITH ONLY THREE ARMS. THE CUSTOMER EXPLAINED THAT THEY WOULD TRY TO FINISH THE PROCEDURE WITH THREE ARMS BUT WOULD LIKE IT TO BE FIXED BEFORE THE SURGERY TOMORROW MORNING. THE OPERATING ROOM (OR) SUPERVISOR CALLED BACK TO REPORT THAT THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. SHE ALSO STATED THAT THE INTERNET CONNECTION WAS RESTORED. THE TSE CONFIRMED ERROR 32098 POINTING TO USM 4. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC. THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISIONS OR ADDITIONAL PORTS. THE CONVERSION TO LAPAROSCOPIC SURGERY WAS SUCCESSFUL AND THE PATIENT TOLERATED THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT." }, { "mdr_text_key": "353250852", "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 ISI FSE WENT ON SITE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE WITH ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE ISI DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE." }, { "mdr_text_key": "355549097", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT CONFIRMED AND REPLICATED ERROR 32098. THE USM WAS TESTED ON A PFTP WHERE YAW DIRECTION TEST PROMPTING ERROR 32098 ON THE MOTOR 6 INSERTION STATOR. A GOLD INSERTION STATOR WAS INSTALLED, AND THE ERROR WENT AWAY. THE ORIGINAL INSERTION STATOR WAS RE-INSTALLED, AND THE ERROR CAME BACK. THE INSERTION STATOR WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS." }, { "mdr_text_key": "355549098", "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": "10/30/2024" } ] }