{ "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": "2955842-2024-14841", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240521", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20240423", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "UK", "manufacturer_contact_area_code": "408", "date_added": "20240521", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210331", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "516779", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240521", "brand_name": "DA VINCI XI", "generic_name": "VISION SIDE SYSTEM, RECONDITIONED", "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": "380721-10", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00886874115343", "udi_public": "(01)00886874115343", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Output Problem", "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/29/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250820", "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": "20240521", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20240423", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19361705", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240423", "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": "343146367", "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 REPLACED THE FOOT PEDAL BIPOLAR AND SERVICED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION." }, { "mdr_text_key": "343146368", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DISPLAYED AN ERROR MESSAGE AND COULD NOT BE USED. THE ISI TSE CHECKED LOGS AND NOTED ERRORS M-12. THE ISI TSE ASKED THE CUSTOMER TO CHECK THE EXTREMAL FOOT PEDALS IN A DRAWER AND ENSURE THEY WERE NOT PUSHED OR STUCK; THE CUSTOMER INFORMED THEY HAD ALREADY DONE SO AND VERIFIED NOTHING PUSHING ON THE PEDALS. THE ISI TSE GUIDED THE CUSTOMER TO DISCONNECT THE EXTERNAL FOOT PEDALS FROM ERBE'S REAR PANEL AND THE ERROR CLEARED. THE ISI TSE INFORMED THE CUSTOMER THAT THE ISI FSE WOULD VISIT TO RESOLVE THE ISSUE PERMANENTLY. THE CUSTOMER CALLED BACK AND REPORTED ERROR HAD RETURNED; THE ERROR MESSAGE RETURNED WHEN THE BIPOLAR EXTERNAL PEDAL WAS PLUGGED IN AND WHEN THE MONOPOLAR WAS DISCONNECTED, THE SURGEON COULD NOT CONTROL ERBE FROM THE SURGEON SIDE CONSOLE (SSC). THE ISI TSE SUGGESTED VERIFYING THE CORRECT CONNECTORS WERE DISCONNECTED, THE CUSTOMER DID SO. THE CUSTOMER NEEDED IESU FOR THE PROCEDURE, SO THE PROCEDURE WAS MOST LIKELY TO BE CONVERTED. THE ISI TSE INFORMED THE CUSTOMER THE FSE WOULD BE NOTIFIED. THE CUSTOMER CALLED BACK AS THEY HAD LOCATED A FORCE TRIAD ESU BUT NEEDED ADVICE ON HOW TO CONNECT TO CORE USING THE DESIGNATED THIRD-PARTY GENERATOR CABLE. THE ISI TSE GUIDED THE CUSTOMER THROUGH THE CONNECTION OF FORCE TRIAD TO CORE. THE CUSTOMER INFORMED THE NEXT SURGERY WOULD TAKE PLACE WITH THE USE OF THIS BACKUP GENERATOR INSTEAD OF ERBE IESU. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY AND COMPLETED WITH NO REPORTED INJURY." }, { "mdr_text_key": "345769754", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER HAD TO ADD 2 MORE 5MM PORTS AND THIS CAUSED NO IMPLICATIONS TO REPORTER'S KNOWLEDGE ON THE PATIENT. THE SITUATION WAS DELT WITH PROMPTLY." }, { "mdr_text_key": "345769755", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/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": "06/21/2024" } ] }