{ "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": "2955842-2025-35513", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250829", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250804", "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": "20250829", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240906", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "94689", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250829", "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": "380601-50", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250926", "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": "20250829", "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": "20250804", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22924063", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250804", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "378851241", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED AFTER PORT PLACEMENT THE TEAM HAD PREPARED A PATIENT FOR A RADICAL EXTRAPERITONEAL PROSTATECTOMY. THE SURGEON, AFTER MAKING THE INITIAL INCISION, INSERTED THE SINGLE PORT (SP) ACCESS PORT INTO THE PATIENT. HOWEVER, WHEN ATTEMPTING TO DOCK THE SP SYSTEM, AN ERROR MESSAGE APPEARED INDICATING THAT THE \"CANNULA WAS INVALID.\" FOLLOWING THE TECHNICAL SUPPORT ENGINEER'S (TSE) RECOMMENDATION, THE TEAM OPENED A SECOND SMALL ACCESS PORT KIT, BUT IT RESULTED IN THE SAME ERROR MESSAGE. A HARD SYSTEM RESTART DID NOT RESOLVE THE ISSUE, SO THE TEAM UNDOCKED THE SP, RE-DRAPED THE SYSTEM, AND ATTEMPTED TO REDOCK, BUT THE ERROR PERSISTED. WITH ADVICE FROM THE TSE, AN ENGINEER VISIT WAS SCHEDULED, CONTINGENT ON RECEIVING SPARE PARTS FROM THE NETHERLANDS. THE PROCEDURE WAS CONVERTED TO A MULTI-PORT DA VINCI XI SYSTEM TO COMPLETE THE PROCEDURE. THE CUSTOMER HAD TO CLOSE THE INITIAL SINGLE ACCESS PORT INCISION THAT WAS MADE ON THE PATIENT AND PUT 4 ADDITIONAL 8MM CANNULAS IN FOR THE XI CASE, WHICH MEANT A DIFFERENT APPROACH WAS USED FOR THE CASE AND NOT THE PLANNED EXTRAPERITONEAL APPROACH. THE TRANSITION TO THE XI SYSTEM AND THE TROUBLESHOOTING EFFORTS CAUSED A DELAY OF APPROXIMATELY 45-60 MINUTES. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "378851242", "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 INITIALLY COULD NOT REPRODUCE THE FAULT USING A NEW SLIGHTLY LARGER PORT ADAPTOR FROM CUSTOMER STOCK. THE FSE LATER FOUND THE ISSUE TO BE RELATED TO THE OUT RIBBON CONNECTION AT THE SINGLE-PORT ONE AXIS MANIPULATOR CONTROLLER BOARD (SOAM) WHICH WAS FOUND TO BE DISCONNECTED. THIS DISCONNECTED RIBBON COULD HAVE BEEN CAUSING INTERMITTENT RECOGNITION ERRORS AND THE RELATED ERROR MESSAGES. THE CANNULA SENSOR LOOM WAS REPLACED. 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. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: \"INVALID CANNULA INSTALLED ON EGM\"." } ], "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": "" } ] }